
[Federal Register Volume 81, Number 243 (Monday, December 19, 2016)]
[Rules and Regulations]
[Pages 91731-91738]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-30193]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 880

[Docket No. FDA-2015-N-0701]


General Hospital and Personal Use Devices: Renaming of Pediatric 
Hospital Bed Classification and Designation of Special Controls for 
Pediatric Medical Crib; Classification of Medical Bassinet

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to rename pediatric hospital beds as pediatric medical cribs and 
establish special controls for these devices. FDA is also establishing 
a separate classification regulation for medical bassinets, previously 
under the pediatric hospital bed classification regulation, as a class 
II (special controls) device. In addition, this rule continues to allow 
both devices to be exempt from premarket notification and use of the 
device in traditional health care settings and permits prescription use 
of pediatric medical cribs and bassinets outside of traditional health 
care settings.

DATES: This order is effective on January 18, 2017.

FOR FURTHER INFORMATION CONTACT: Michael J. Ryan, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1615, Silver Spring, MD 20993-0002, 301-
796-6283.

SUPPLEMENTARY INFORMATION: 

Table of Contents

I. Executive Summary
    A. Purpose and Coverage of the Final Rule
    B. Summary of the Major Provisions of the Final Rule
    C. Legal Authority
    D. Costs and Benefits
II. Background
    A. Need for the Regulation/History of This Rulemaking
    B. Summary of Comments to the Proposed Rule
    C. General Overview of Final Rule
III. Legal Authority
IV. Comments on the Proposed Rule and FDA Response
    A. Introduction
    B. Specific Comments and FDA Response
    C. Clarifying Changes to the Rule
V. Effective/Compliance Dates
VI. Economic Analysis of Impacts
VII. Analysis of Environmental Impact
VIII. Paperwork Reduction Act of 1995
IX. Federalism
X. References

I. Executive Summary

A. Purpose and Coverage of the Final Rule

    Pediatric medical cribs that meet the definition of a device in 
section 201(h) of the Federal Food, Drug, and Cosmetic Act (the FD&C 
Act) (21 U.S.C. 321(h)) (referred to as pediatric medical cribs or 
cribs intended for medical purposes) (product code FMS) are regulated 
by FDA and will have to comply with the special controls identified in 
this rule for pediatric medical cribs. Cribs that do not meet the 
device definition (referred to as cribs for non-medical purposes) must 
meet the Consumer Product Safety Commission's (CPSC's) regulations and 
guidelines.
    In the Federal Register of December 28, 2010 (75 FR 81766), the 
CPSC issued a final rule prohibiting the use of the drop-side rail 
design for non-medical cribs in consumer households as of June 28, 
2011. CPSC's rule established new standards for full-size and non-full-
size cribs intended for non-medical purposes, which effectively 
prohibited the manufacture or sale of cribs intended for non-medical 
purposes with a drop-side rail design in households, child care 
facilities, family child care homes, and places of public 
accommodation. This rule did not affect pediatric medical cribs 
regulated by FDA, which typically contain a drop-side rail design that 
includes movable and latchable side and end rails. Although drop-side 
cribs intended for non-medical purposes are now prohibited, there is 
still a need for pediatric medical cribs with drop-side rails inside 
and outside of traditional health care settings. Pediatric medical 
cribs with drop-side rails are extremely helpful for patient care in 
hospital settings and even outside of traditional health care settings, 
such as day care centers caring for infants and children with 
disabilities, because they allow parents and care givers easy access to 
children to perform routine and emergency medical procedures, 
including, but not limited to, cardiopulmonary resuscitation (CPR), 
blood collection, intravenous (IV) insertion, respiratory care, and 
skin care. These drop-side rail cribs also make it easier for hospital 
staff to facilitate safe patient transport and reduce the chance of 
care giver injury.
    Over the last 5 years, FDA has received over 500 adverse event 
reports, or Medical Device Reports (MDRs), associated with open 
pediatric medical cribs, through the Agency's Manufacturer and User 
Facility Device Experience (MAUDE) database. There were adverse event 
reports of serious injuries, including reports of entrapment, which 
were predominantly entrapments of extremities (legs or arms). The 
majority of MDRs for medical cribs were for malfunctions such as drop-
side rails not latching or lowering, brakes not holding, wheels or 
casters breaking, and where applicable, scales not reading correct 
weights. As a result of the risks to health and need for continued use 
of pediatric medical cribs in traditional health care settings and non-
traditional settings, FDA is revising the identification for Sec.  
880.5140 (21 CFR 880.5140) to include only pediatric

[[Page 91732]]

medical cribs, establishing special controls for these devices, and 
changing the name of the classification regulation.
    In addition, FDA has received adverse event reports from hospitals 
regarding incidents of medical bassinet tipping and improper cleaning 
of the basket or bed component that caused cracks and crazing, which 
have resulted in patient injury. Historically, medical bassinets have 
been regulated as pediatric hospital beds (Sec.  880.5140, product code 
NZG). As a result, this rule creates a separate regulation for medical 
bassinets and establishes special controls for this device type to 
provide a reasonable assurance of safety and effectiveness.

B. Summary of the Major Provisions of the Final Rule

    In this final rule, FDA is amending the classification ``pediatric 
hospital bed'' in Sec.  880.5140 to change the name of the 
classification regulation from ``pediatric hospital bed'' to 
``pediatric medical crib'' and imposing special controls for pediatric 
medical cribs to provide a reasonable assurance of safety and 
effectiveness for these devices. This rule also creates a separate 
regulation, under Sec.  880.5145, for medical bassinets and imposes 
special controls for this device type to provide a reasonable assurance 
of safety and effectiveness. In addition, use of pediatric medical 
cribs and medical bassinets outside of traditional health care settings 
will be limited to prescription use in accordance with Sec.  801.109 
(21 CFR 801.109). The Agency believes that the applicable special 
controls established and imposed by this final rule, together with the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of these devices. Also, once this rule is effective, the 
Agency will move the following medical devices listed under Sec.  
880.5140 to classification regulations of other class II devices with 
similar intended uses and premarket notification requirements: 
Pediatric cribs with integrated air mattresses; youth beds; pediatric 
stretchers; and crib enclosure beds as identified in section II.C of 
this final rule.

C. Legal Authority

    Pediatric medical cribs and medical bassinets are medical devices 
under section 201(h) of the FD&C Act. For devices, FDA has the 
authority under section 513(a)(1)(B) of the FD&C Act (21 U.S.C. 
360c(a)(1)(B)) to issue a regulation to establish special controls for 
class II devices for which general controls by themselves are 
insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls to provide such assurance. Under this authority, FDA is 
establishing special controls for the class II pediatric medical cribs 
and medical bassinets (Sec. Sec.  880.5140 and 880.5145).

D. Costs and Benefits

    This rule establishes special controls for medical bassinets and 
pediatric medical cribs, and permits use of these devices outside of 
traditional health care settings for prescription use only. This 
regulation will also change the name of the classification regulation 
for ``pediatric hospital beds'' to ``pediatric medical cribs'' and 
establish a separate classification regulation for medical bassinets as 
a class II device. The special control requirements set forth in this 
rule will clarify safety standards and minimize the risk of injury to 
pediatric patients, providing reasonable assurance of safety and 
effectiveness. The special control requirements that are definitely not 
currently practiced are the warning labeling requirements for both 
devices. The special controls will clarify for manufacturers the safety 
standards and help minimize the risk of injury to pediatric patients. 
The benefits of the new warning label are not readily quantifiable, but 
it is expected to reduce the risk of the bassinet from tipping or other 
user error and thus, reduce potential injury to pediatric patients. 
Additionally, the provision permitting prescription use of medical 
bassinets and pediatric medical cribs outside of traditional health 
care settings will benefit pediatric patients who require the 
specialized care provided by these devices. Costs estimated in this 
analysis include costs related to the new warning labeling 
requirements, the prescription use and performance testing for medical 
bassinets and pediatric medical cribs, as well as physical modification 
of pediatric cribs. The annual costs are $2,379,400, and include the 
costs of the warning labels and prescription provision. The cost of 
performance testing is $3,360 per unit and the cost of modifying a 
pediatric crib is $1,125 per unit.

II. Background

    The FD&C Act (21 U.S.C. 301 et seq.), as amended, establishes a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the FD&C Act establishes three categories 
(classes) of devices, based on the regulatory controls needed to 
provide reasonable assurance of their safety and effectiveness. The 
three categories of devices are class I (general controls), class II 
(special controls), and class III (premarket approval).
    Most generic types of devices that were on the market before May 
28, 1976, the date of the 1976 amendments (generally referred to as 
preamendments devices), have been classified by FDA through the 
issuance of regulations in accordance with the procedures set forth in 
section 513(c) and (d) of the FD&C Act into one of these three 
regulatory classes. Devices introduced into interstate commerce for the 
first time on or after May 28, 1976 (generally referred to as post-
amendments devices), are automatically classified by section 513(f) of 
the FD&C Act into class III without any FDA rulemaking process. These 
devices remain in class III and require premarket approval, unless FDA 
initiates one of the following procedures: (1) FDA reclassifies the 
device into class I or II; (2) FDA issues an order classifying the 
device into class I or II in accordance with section 513(f)(2) of the 
FD&C Act; or (3) FDA issues an order finding the device to be 
substantially equivalent, under section 513(i) of the FD&C Act, to a 
predicate device that is already legally marketed. The Agency 
determines whether new devices are substantially equivalent to 
predicate devices through review of premarket notifications under 
section 510(k) of the FD&C Act (21 U.S.C. 360(k)). Section 510(k) of 
the FD&C Act and its implementing regulations, codified in title 21 of 
the Code of Federal Regulations (21 CFR) part 807, subpart E, require 
persons who intend to market a new device that does not require a 
premarket approval application under section 515 of the FD&C Act (21 
U.S.C. 360e) to submit a premarket notification (510(k)) containing 
information that allows FDA to determine whether the new device is 
``substantially equivalent'' within the meaning of section 513(i) of 
the FD&C Act to a legally marketed device that does not require 
premarket approval.
    Section 513(a)(1)(B) of the FD&C Act defines class II devices as 
those devices for which the general controls in section 513(a)(1)(A) by 
themselves are insufficient to provide reasonable assurance of safety 
and effectiveness, but for which there is sufficient information to 
establish special controls to provide such assurance, including the 
issuance of performance standards, postmarket surveillance, patient 
registries, development and dissemination of guidelines, 
recommendations, and any other appropriate actions the Agency deems 
necessary to provide such assurance (see also 21 CFR 860.3(c)(2)).

[[Page 91733]]

    Section 510(m)(2) of the FD&C Act provides that FDA may exempt a 
class II device from the premarket notification requirements on its own 
initiative or upon petition of an interested person, if FDA determines 
that a 510(k) is not necessary to provide reasonable assurance of the 
safety and effectiveness of the device. Devices under the pediatric 
hospital bed classification regulation, including pediatric cribs and 
medical bassinets, were made exempt from premarket notification, 
subject to certain limitations, in accordance with section 510(m) of 
the FD&C Act (63 FR 59222 at 59229, November 3, 1998).

A. Need for the Regulation/History of This Rulemaking

    Pediatric medical cribs are medical devices intended for the 
treatment, cure, or mitigation of diseases or illnesses of pediatric 
patients. Prior to the issuance of this final rule, a pediatric 
hospital bed is was defined as ``a device intended for medical purposes 
that consists of a bed or crib designed for the use of a pediatric 
patient, with fixed end rails and movable and latchable side rails. The 
contour of the bed surface may be adjustable.'' FDA classified 
pediatric medical cribs in 1980 as pediatric hospital beds (Sec.  
880.5140, product code FMS), class II devices (45 FR 69678 at 69695, 
October 21, 1980), and exempted them in 1998 from premarket 
notification (510(k)) under section 510(m) of the FD&C Act in the final 
rule (63 FR 59222 at 59229). Pediatric medical cribs with drop-side 
rails are extremely helpful for patient care in hospital settings and 
even outside of traditional health care settings, such as day care 
centers caring for infants and children with disabilities, because they 
allow parents and care givers easy access to children in order to 
perform routine and emergency medical procedures, including, but not 
limited to, CPR, blood collection, IV insertion, respiratory care, and 
skin care.
    FDA published a proposed rule in the Federal Register of October 8, 
2015 (80 FR 60809), proposing to (1) change the identification and name 
of Sec.  880.5140, Pediatric hospital bed to Pediatric medical crib, 
and remove references to ``beds'' within the regulation, as 
appropriate, (2) establish special controls for pediatric medical 
cribs, (3) rearrange the devices within Sec.  880.5140 so that it 
includes only pediatric medical cribs and move other devices that were 
within the prior hospital bed regulation to more appropriate 
classification regulations, and (4) create a separate regulation for 
medical bassinets with special controls. This rule finalizes those 
proposals.
    Pediatric medical cribs that meet the definition of a device in 
section 201(h) of the FD&C Act are regulated by FDA. Cribs that do not 
meet the definition of device must meet the CPSC's regulations and 
guidelines. Because drop-side rail cribs for non-medical purposes and 
pediatric medical cribs are regulated by different agencies, CPSC 
consulted with FDA about the impact their final rule (75 FR 81766) 
could have on settings, such as nursery schools and day care centers, 
where pediatric medical cribs with drop-side rails are often used for 
pediatric patients after they have been discharged from a health care 
facility. In comparison to CPSC's experience with drop-side rail cribs 
for non-medical purposes, FDA received fewer and less severe adverse 
event reports for pediatric medical cribs with the drop-side design. In 
addition, FDA determined that there is a need for continued access to 
pediatric medical cribs with drop-side rails inside and outside of 
traditional health care settings because of the utility of the drop-
side design (Ref. 1). Based on the consultation with CPSC, FDA 
determined that it should establish special controls to provide 
reasonable assurance of the safety and effectiveness of pediatric 
medical cribs and permit continued use of these devices outside of 
traditional health care settings.
    This rule also creates a separate classification regulation for 
medical bassinets, Sec.  880.5145. Historically, medical bassinets have 
also been regulated as pediatric hospital beds (Sec.  880.5140, product 
code NZG). A medical bassinet is a non-powered device that consists of 
two components: (1) A basket, the sleep or bed component, which is 
typically made of plastic and (2) a frame with wheels, which holds the 
basket or bed component (FDA refers to this component as a ``basket or 
bed component'' interchangeably in this rule). The basket or bed 
component is a box-like structure, generally made of a clear, high-
impact resistant plastic material, with an open top and four walls to 
keep the infant in place. Medical bassinets are typically used in 
hospital settings for infants up to 5 months in age. The beneficial 
features of medical bassinets are portability, ease of cleaning, and, 
when it is made of a clear material, the ability to see the infant from 
all sides.
    Based on the risks to health identified in FDA's proposed rule for 
pediatric medical cribs and bassinets, along with MDRs the Agency 
received from January 2005 to September 2015, FDA determined that 
general controls alone are insufficient to provide a reasonable 
assurance of safety and effectiveness for these devices for their 
intended use. Thus, with this rule, FDA is imposing special controls on 
these devices, which along with general controls, will provide 
reasonable assurance of safety and effectives of these devices and will 
permit their continued use in traditional health care settings. FDA 
will also permit the use of pediatric medical cribs with drop-side rail 
designs and bassinets outside of traditional health care settings 
through prescription use only. The special controls are designed to 
address the adverse event reports for pediatric medical cribs and 
bassinets. For pediatric medical cribs, there were adverse event 
reports of serious injuries including reports of entrapment, which were 
predominantly extremity entrapments of legs or arms. The majority of 
these reports were for malfunctions such as drop-side rails not 
latching or lowering, brakes not holding, wheels or casters breaking, 
and where applicable, scales not reading correct weights. For medical 
bassinets, hospitals have reported to FDA incidents of tipping and 
improper cleaning of the basket or bed component that caused cracks and 
crazing, which have resulted in patient injury.

B. Summary of Comments to the Proposed Rule

    FDA requested comments on the proposed rule (80 FR 60809), and the 
comment period closed on December 7, 2015. The Agency received 11 
comments on the proposed rule by the close of the comment period; some 
of the comments contained comments on more than one issue. We received 
comments from a cross-section of consumers, device manufacturers, and 
professional and trade associations. All of the comments supported the 
changes identified in the proposed rule in whole or in part; however, 
some comments suggested changes to the proposed special controls or 
requested clarification of matters discussed in the proposed rule. See 
section IV for the description of comments on the proposed rule and 
FDA's responses.

C. General Overview of Final Rule

    FDA is amending the classification pediatric hospital bed in Sec.  
880.5140 to change the name of the classification regulation from 
``pediatric hospital bed'' to ``pediatric medical crib'' and to 
establish special controls for pediatric medical cribs to provide a 
reasonable assurance of safety and effectiveness. This rule also 
creates a separate regulation, under Sec.  880.5145, for

[[Page 91734]]

medical bassinets and establishes special controls for this device type 
to provide a reasonable assurance of safety and effectiveness. In 
addition, use of pediatric medical cribs and medical bassinets outside 
of traditional health care settings will be limited to prescription use 
in accordance with Sec.  801.109. The Agency believes that the 
applicable special controls, together with the general controls, will 
provide reasonable assurance of the safety and effectiveness of these 
devices.
    Devices that do not meet the final identification under Sec.  
880.5140 for ``pediatric medical crib'' will be administratively moved 
to more appropriate class II regulations for devices with more similar 
intended uses that are also class II, 510(k) exempt, and will not be 
located under the final pediatric medical crib classification 
regulation. Shortly after the effective date of this final rule, FDA 
will send manufacturers of the remaining pediatric hospital beds 
notices identifying the new classification regulation and product code 
under which the device will be classified. These devices include: Open 
pediatric medical cribs, medical bassinets, pediatric cribs with 
integrated air mattresses, youth beds, pediatric stretchers, and crib 
enclosure beds. A more complete list of the devices fromSec.  880.5140 
and to where they are being moved is provided in table 1.
    This action will not have any substantive effect on the current 
marketing status of the devices. However, manufacturers of these 
devices will need to refer to the new regulation classification and 
product code provided by the Agency in future interactions with FDA.

          Table 1--Medical Devices Removed From Sec.   880.5140
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       New CFR regulation          Classification name     Device class
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21 CFR 890.5170................  Pediatric cribs with                 II
                                  integrated air
                                  mattresses.
21 CFR 880.5100 or 21 CFR        Youth Beds.............              II
 880.5120 (depending on whether
 they are powered).
21 CFR 880.6910................  Pediatric Stretchers...              II
21 CFR 880.6760................  Crib Enclosure Beds....              II
------------------------------------------------------------------------

III. Legal Authority

    Pediatric medical cribs and medical bassinets are defined as 
medical devices under section 201(h) of the FD&C Act. For devices, FDA 
has the authority under section 513(a)(1)(B) of the FD&C Act to issue a 
regulation to establish special controls for class II devices for which 
general controls by themselves are insufficient to provide reasonable 
assurance of safety and effectiveness, but there is sufficient 
information to establish special controls to provide such assurance. 
Under this authority, FDA is establishing special controls for the 
class II pediatric medical cribs and bassinets (Sec. Sec.  880.5140 and 
880.5145).

IV. Comments on the Proposed Rule and FDA's Responses

A. Introduction

    In response to the proposed rule (80 FR 60809) to revise Sec.  
880.5140 to specify that it will only be for regulation of pediatric 
medical cribs, with proposed special controls and to create a separate 
regulation for medical bassinets, also with proposed special controls, 
FDA received 11 comments to Docket No. FDA-2015-N-0701. The comments 
and FDA's responses to the comments are summarized in this document. 
Certain comments are grouped together under a single number because the 
subject matter of the comments is similar. The number assigned to each 
comment is purely for organizational purposes and does not signify the 
comment's value or importance or the order in which it was submitted.

B. Specific Comments and FDA Response

    (Comment 1) Multiple comments made recommendations that we revise 
the requirements for medical bassinet warning labels. One comment 
suggested that the warning label be affixed in a prominent location; 
another comment recommended that the warning label be required to be 
permanently affixed on all sides of the bassinet. One comment also 
recommended that the special control require 9 point font for 
visibility.
    (Response 1) FDA believes that a warning label for medical 
bassinets should be readable, prominent, and in the same location on 
each device. While the proposed rule required the warning label to be 
placed on the bassinet cabinet, FDA has determined that some medical 
bassinets do not include a ``cabinet,'' but all of the devices do have 
a plastic basket or bed component. As a result, FDA has revised the 
special control requiring a warning label to specify that the label 
will need to be affixed to at least two sides of the plastic basket or 
bed component of the bassinet with the language in text of at least 9 
millimeters in height.
    (Comment 2) FDA received a comment requesting that FDA require 
warning labels for pediatric medical cribs.
    (Response 2) Based on the adverse event reports received on 
pediatric medical cribs, FDA agrees that a warning label is warranted 
for pediatric medical cribs. These devices have a number of moving 
parts that can present a risk of head and limb entrapment, crushing, 
pinching, and lacerations to a pediatric patient. FDA has therefore 
revised the special controls for pediatric medical cribs to include a 
labeling requirement that mandates that a warning label be affixed to 
the medical crib that states that pediatric patients must be attended 
at all times whenever a movable side of the crib is in its lowest, or 
most open, position when accessing the child. This will serve as a 
mitigation for the risks of physical harm, such as falling out of the 
crib and possible pinching or lacerations to pediatric patients and 
help provide a reasonable assurance of safety and effectiveness of the 
device.
    (Comment 3) Multiple comments requested clarification of the scope 
of the rule and the applicability of the special controls. One comment 
requested that the special controls identified in this rule apply to 
devices that have already been sold in interstate commerce.
    (Response 3) After the effective date of this rule, manufacturers 
of pediatric medical cribs or medical bassinets, whether or not they 
have been legally marketed prior to January 18, 2017, must comply with 
the special controls identified in this rule to provide a reasonable 
assurance of safety and effectiveness of these devices. However, FDA 
does not intend to enforce the special controls for devices legally 
marketed prior to this date due to the logistical issues associated 
with requiring manufacturers to locate devices that have been sold.
    (Comment 4) One comment suggested that we provide educational 
material for

[[Page 91735]]

users of prescription medical pediatric cribs in non-traditional health 
care settings that address use errors.
    (Response 4) The FD&C Act and its implementing regulations require 
all devices to be accompanied by adequate instructions for use (see 
section 502(f) of the FD&C Act (21 U.S.C. 352(f)) and Sec.  801.5). In 
addition, the special controls identified in this rule include a 
requirement for ``adequate instructions for users to care for, 
maintain, and clean the crib'' and for warning labels alerting users to 
risks associated with crib use. The Agency believes these requirements 
sufficiently address the commenter's concern regarding use error.
    (Comment 5) One comment stated that this rule should not affect 
contractors or business owners who provide a unique service or product.
    (Response 5) To the extent the unique product referred to in the 
comment is a pediatric medical crib or medical bassinet that meets the 
definition of a custom device in section 520(b) of the FD&C Act (21 
U.S.C. 360j(b)), these devices are exempt from, among other things, 
premarket approval requirements and conformance to mandatory 
performance standards (sections 514 and 515 of the FD&C Act (21 U.S.C. 
360d and 360e)). However, the definition of custom device is narrow and 
requires a fact specific analysis. FDA expects that few ``unique'' 
pediatric medical cribs or bassinets will qualify as custom devices. 
FDA notes that patient-specific or patient-matched devices--those that 
have ranges of different specifications on one general design--are not 
generally regarded as custom devices. Manufacturers should see FDA's 
``Custom Device Exemption'' guidance document for more information 
(Ref. 2). It is important that this rule apply to all pediatric medical 
cribs and bassinets that do not meet the custom device exemption to 
provide the broadest protection to users.
    (Comment 6) One comment requested that we expand the device 
identification for pediatric medical cribs to include specialty cribs 
that allow parents who are disabled to access their children.
    (Response 6) This rule establishes an identification and special 
controls specific to pediatric medical cribs intended for medical 
purposes and use with a pediatric patient. FDA developed the special 
controls only after considering the manufacture, use, and risks to 
health specific to these cribs. The special controls were not developed 
with other cribs, such as the specialty cribs described in the comment, 
in mind. As a result, FDA disagrees with including specialty cribs used 
by disabled parents for access to their children under this regulation 
classification.
    (Comment 7) One comment requested that FDA make the following 
changes to the proposed rule regarding pediatric medical crib 
dimensions: (1) Citing FDA's reference of ASTM F1169-13 (formerly the 
American Society for Testing and Materials), section 5.7.2.1, in 
relation to rail height requirement, the commenter stated that, ``Based 
on user need we believe that this reference should be removed to allow 
for full access to the patient without interference from the siderail 
[sic] in the lowest height position.'' The commenter stated that they 
believe dimensions should be determined through the design process and 
should balance risks and benefits. (2) The proposed rule suggested that 
``no gap shall exist between the edge of the bottom rail and the top of 
the mattress surface,'' based on ASTM F1169-13. The commenter proposed 
instead that, based on International Electrotechnical Commission (IEC) 
60601-2-52, a maximum gap of 2\3/8\ inches be allowed. The commenter 
stated that a requirement for ``no gap'' would be practically difficult 
to design. (3) The commenter also pointed out that the proposed 
requirement for the height of the side rail is inconsistent with the 
requirement provided by ASTM F1169-13, section 5.7.2.2, and recommended 
harmonization with ASTM F1169-13.
    (Response 7) FDA agrees that clarification of dimensional 
requirements is needed for the special controls to mitigate entrapment, 
pinching, lacerations, and other risks associated with pediatric 
medical cribs. The Agency responds to the previous comments as follows: 
(1) Given the many potential differences in crib designs, including 
different mattress heights, a specific requirement for the height of a 
pediatric medical crib's side rail at the lowest position is 
unnecessary and may not mitigate the risk of falls as effectively in 
all designs. As a result, FDA has removed the specific height 
requirement when side rails are in their lowest position, but revised 
the height requirement when the rail is in the highest position (as 
described as follows in this response). Also, FDA has added a 
requirement for a warning label that states that pediatric patients 
should be attended to whenever a rail is in its lowest, or most open, 
position, regardless of design, to monitor and mitigate the risk of the 
patient falling out of the medical crib.
    (2) FDA agrees that it may be difficult to design for ``no gap''; 
however, the Agency does not agree that 2\3/8\ inches is an appropriate 
maximum dimension, as this may leave room for entrapment or 
impingement. FDA has revised the special controls to eliminate the 
requirement for ``no gap,'' but is retaining the requirement that crib 
mattresses must fit tightly around all four sides of the crib, such 
that the occurrence of entrapment and impingement is prevented.
    (3) FDA agrees that the proposed requirement height of 20 inches 
was incorrect because the measurement failed to include the CPSC 
standard as required in CPSC's guidance entitled ``Full-Size Baby Crib 
Business Guidance'' for a pediatric medical crib mattress that requires 
the height measurement for the mattress to be 6 inches thick (Ref. 3). 
As a result, FDA is revising the special control requirement to be 
consistent with that standard. The height of the rail and end panel as 
measured from the top of the rail or panel in its highest position to 
the top of the mattress support in its lowest position shall be at 
least 26 inches (66 centimeters). The mattress will also be required to 
not exceed 6 inches in thickness. This requirement is to ensure that 
high mattresses do not create a hazard by reducing the rail height.
    (Comment 8) One comment opposed the proposed rule because it did 
not require any safety testing data be reviewed by FDA. According to 
the commenter, testing was especially important given the lack of 
scientific evidence that drop-side rail cribs provide important 
benefits in hospital settings.
    (Response 8) Section 510(m)(2) of the FD&C Act permits FDA to 
exempt a class II device from the premarket notification requirements 
on its own initiative or upon petition of an interested person, if FDA 
determines that a 510(k) is not necessary to provide reasonable 
assurance of the safety and effectiveness of the device. Pediatric 
medical cribs have been exempt from premarket notification since 1998 
and they have been essential to the provision of efficient medical care 
to pediatric patients since they entered the market. FDA reviewed the 
MedSun Survey (Ref. 1) and analyzed the MDRs submitted to the MAUDE 
database for medical cribs to identify the relevant risks to health 
associated with these devices (section IV of the proposed rule) and 
determined that, based on these risks, the number of MDRs received, and 
FDA's experience with these devices, there is sufficient information 
available to establish special controls that in combination with the 
general controls will provide a reasonable assurance of

[[Page 91736]]

safety and effectiveness by mitigating the risks to health associated 
with these devices (section VI of the proposed rule) without the need 
to reinstate the requirement for 510(k) review. The special controls 
require manufacturers to perform appropriate testing to demonstrate the 
mechanical and structural stability of their pediatric medical cribs, 
among other things. As a result, FDA does not agree that it needs to 
review the testing data through review of a manufacturer's premarket 
notification (510(k)) to provide reasonable assurance of the safety and 
effectiveness.
    (Comment 9) One comment suggested that FDA make the effective date 
120 days after the publication of this rule to allow manufacturers of 
devices legally on the market to have time to conduct gap analysis, 
plan for design changes, and comply with other special controls.
    (Response 9) FDA does not intend to extend the effective date to 
120 days for the established special controls in this rule for both 
pediatric medical cribs and bassinets because many of the special 
controls in this rule are consistent with current industry practice 
among many manufacturers of products currently on the market. As stated 
earlier, due to the CPSC rule prohibiting the use of cribs with a drop-
side rail design for non-medical purposes, FDA believes it is necessary 
to allow consumers to use pediatric medical cribs and bassinets in non-
traditional health care facilities as soon as possible if they are 
prescribed by a health care professional. As a result, FDA has decided 
to change the effective date from the proposed 60 days stated in the 
proposed rule to now being 30 days after its publication in the Federal 
Register as stated in this final rule to provide a reasonable assurance 
of safety and effectiveness of these devices.
    Also, FDA is unaware of a possible shortage of devices entering the 
market due to manufacturers having to comply with the new special 
controls; however, FDA does not intend to enforce compliance with the 
special controls for manufacturers of new devices until they have been 
brought onto the market.

C. Clarifying Changes to the Rule

    In addition to the revisions made to the special controls for 
pediatric medical cribs and bassinets based on the comments submitted 
for the proposed rule, FDA is making additional clarifying changes to 
the special controls. FDA has determined that CPSC's Standard for the 
Flammability of Mattresses and Mattress Pads (FF 4-72, Amended) and 
Standard for the Flammability (Open Flame) of Mattress Sets (16 CFR 
parts 1632 and 1633) are inapplicable to medical bassinets because the 
mattresses for medical bassinets do not meet the measurements required 
for CPSC's mattress flammability standards. FDA is therefore removing 
this special control.
    In addition, FDA has revised the labeling special control for both 
medical cribs and medical bassinets to include adequate instructions 
for cleaning of the device. The labeling for adequate maintenance of a 
bassinet should include the use of proper cleaning materials to allow 
safe and continuous use of these devices for both pediatric patients 
and personnel in traditional health care settings.
    FDA believes that the special controls, listed in the revised 
regulations Sec.  880.5140 and new regulation Sec.  880.5145, in 
combination with the general controls, will provide a reasonable 
assurance of safety and effectiveness for pediatric medical cribs and 
medical bassinets for their intended use.

V. Effective/Compliance Dates

    This final rule will become effective 30 days after its publication 
in the Federal Register.

VI. Economic Analysis of Impacts

    We have examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct us to assess all costs 
and benefits of available regulatory alternatives and, when regulation 
is necessary, to select regulatory approaches that maximize net 
benefits (including potential economic, environmental, public health 
and safety, and other advantages; distributive impacts; and equity). We 
have developed a comprehensive Economic Analysis of Impacts that 
assesses the impacts of the final rule. We believe that this final rule 
is not a significant regulatory action as defined by Executive Order 
12866.
    The Regulatory Flexibility Act requires us to analyze regulatory 
options that would minimize any significant impact of a rule on small 
entities. Because the expected costs associated with this rule are 
expected to be modest, we certify that the final rule will not have a 
significant economic impact on a substantial number of small entities.
    The Unfunded Mandates Reform Act of 1995 (section 202(a)) requires 
us to prepare a written statement, which includes an assessment of 
anticipated costs and benefits, before issuing ``any rule that includes 
any Federal mandate that may result in the expenditure by State, local, 
and tribal governments, in the aggregate, or by the private sector, of 
$100,000,000 or more (adjusted annually for inflation) in any one 
year.'' The current threshold after adjustment for inflation is $146 
million, using the most current (2015) Implicit Price Deflator for the 
Gross Domestic Product. This final rule would not result in an 
expenditure in any year that meets or exceeds this amount.
    This rule establishes special controls for medical bassinets and 
pediatric medical cribs, and permits prescription use of these devices 
outside of traditional health care settings. This regulation will also 
change the name of the classification regulation for ``pediatric 
hospital beds'' to ``pediatric medical cribs'' and establish a separate 
classification regulation for medical bassinets as a class II device. 
The special control requirements set forth in this rule will clarify 
safety standards to help minimize the risk of injury to pediatric 
patients posed by these devices. Additionally, permitting use of 
pediatric medical cribs by prescription outside of traditional health 
care settings will benefit pediatric patients who require the 
specialized care provided by these devices. Costs estimated in this 
analysis include costs related to the new warning labeling 
requirements, the prescription and performance testing for medical 
bassinets and pediatric medical cribs, along with physical modification 
of pediatric medical crib design. The annual costs are $2,379,400, and 
include the costs of the warning labels and prescription provision. The 
cost of performance testing is $3,360 per unit and the cost of 
modifying a pediatric crib is $1,125 per unit.
    The full discussion of economic impacts is available in Docket No. 
FDA-2015-N-0701 and at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm (Ref. 4).

VII. Analysis of Environmental Impact

    The Agency has determined under 21 CFR 25.34(b) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

VIII. Paperwork Reduction Act of 1995

    The final rule refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to

[[Page 91737]]

review by the Office of Management and Budget (OMB) and the Paperwork 
Reduction Act of 1995 (44 U.S.C. 3501-3520). The collections of 
information regarding premarket notification submissions (part 807, 
subpart E), are approved under OMB control number 0910-0120. The 
collections of information regarding labeling (21 CFR part 801), 
including prescription device labeling and adequate directions for use, 
are approved under OMB control number 0910-0485. The collections of 
information regarding current good manufacturing practice quality 
systems (21 CFR part 820), including design controls (as referenced in 
Sec. Sec.  880.5140(b)(1) and 880.5145(b)(1) and (3) of this document), 
are approved under OMB control number 0910-0073. The collections of 
information in 16 CFR parts 1632 and 1633, regarding mattress 
flammability, are approved under OMB control number 3041-0014.
    In addition, FDA concludes that the warning labels for pediatric 
medical cribs and medical bassinets are not subject to review by OMB 
because they do not constitute a ``collection of information'' under 
the PRA. Rather, the labeling statements are ``public disclosure(s) of 
information originally supplied by the Federal government to the 
recipient for the purpose of disclosure to the public'' (5 CFR 
1320.3(c)(2)).

IX. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that would have substantial direct effects on 
the States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

X. References

    The following references are on display in the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
rm. 1061, Rockville, MD 20852, and are available for viewing by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday; 
they are also available electronically at http://www.regulations.gov. 
FDA has verified the Web site addresses, as of the date this document 
publishes in the Federal Register, but Web sites are subject to change 
over time.

1. MedSun Newsletter #66, ``Pediatric Hospital Cribs: MedSun Small 
Sample Survey Summary'' (November 2011), available at http://www.fda.gov/downloads/MedicalDevices/Safety/MedSunMedicalProductSafetyNetwork/Newsletters/UCM422131.pdf.
2. FDA, ``Custom Device Exemption; Guidance for Industry and Food 
and Drug Administration Staff,'' (September 24, 2014), available at 
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM415799.pdf.
3. Consumer Product Safety Commission, ``Full-Size Baby Cribs 
Business Guidance,'' available at http://www.cpsc.gov/en/Business--
Manufacturing/Business-Education/Business-Guidance/Full-Size-Baby-
Cribs/.
4. Final Regulatory Impact Analysis, Final Regulatory Flexibility 
Analysis, and Unfunded Mandates Reform Act Analysis for Requirements 
for General Hospital and Personal Use Devices: Renaming of Pediatric 
Hospital Bed Classification and Designation of Special Controls for 
Pediatric Medical Crib; Classification of Medical Bassinet, 
available at http://www.fda.gov/AboutFDA/ReportsManualsForms/Reports/EconomicAnalyses/default.htm.

List of Subjects in 21 CFR Part 880

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
880 is amended as follows:

PART 880--GENERAL HOSPITAL AND PERSONAL USE DEVICES

0
1. The authority citation for part 880 continues to read as follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Revise Sec.  880.5140 to read as follows:


Sec.  880.5140   Pediatric medical crib.

    (a) Identification. A pediatric medical crib is a prescription 
device intended for medical purposes for use with a pediatric patient 
that consists of an open crib, fixed end rails, movable and latchable 
side rail components, and possibly an accompanying mattress. The 
contour of the crib surface may be adjustable.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec.  880.9. The special controls for 
this device are:
    (1) Crib design and performance testing shall demonstrate the 
mechanical and structural stability of the crib under expected 
conditions of use, including the security of latches and other locking 
mechanisms when engaged;
    (2) Materials used shall be appropriate for the conditions of use, 
allow for proper sanitation, and be free from surface defects that 
could result in injuries;
    (3) The height of the rail and end panel as measured from the top 
of the rail or panel in its highest position to the top of the mattress 
support in its lowest position shall be at least 26 inches (66 
centimeters). Any mattress used in this crib must not exceed a 
thickness of 6 inches;
    (4) Hardware and fasteners shall be designed and constructed to 
eliminate mechanical hazards to the patient;
    (5) The distance between components of the side rail (i.e., slats, 
spindles, and corner posts) shall not be greater than 2\3/8\ inches (6 
centimeters) apart at any point;
    (6) The mattress must fit tightly around all four sides of the crib 
base, such that entrapment or impingement of occupant is prevented;
    (7) The mattress for the crib shall meet the Consumer Product 
Safety Commission (CPSC) Standard for the flammability of mattresses 
and mattress pads (FF 4-72, amended) and Standard for the flammability 
(open flame) of mattress sets, 16 CFR parts 1632 and 1633, 
respectively; and
    (8) Each device must have the following label(s) affixed:
    (i) Adequate instructions for users to care for, maintain, and 
clean the crib; and
    (ii) A warning label on at least two sides of the medical crib with 
the following language in text of at least 9 millimeters in height:

WARNING: Never leave a child unsupervised when the moveable side is 
open or not secured.

0
3. Add Sec.  880.5145 to subpart F to read as follows:


Sec.  880.5145   Medical bassinet.

    (a) Identification. A medical bassinet is a prescription device 
that is a small bed intended for use with pediatric patients, generally 
from birth to approximately 5 months of age. It is intended for medical 
purposes for use in a nursery, labor and delivery unit, or patient 
room, but may also be used outside of traditional health care settings. 
A medical bassinet is a non-powered device that consists of two 
components: The plastic basket or bed component and a durable frame 
with wheels, which holds the basket or bed

[[Page 91738]]

component. The basket or bed component is a box-like structure, 
generally made of a clear, high impact-resistant plastic material, with 
an open top and four stationary walls to hold the pediatric patient. 
The frame can include drawers, shelving, or cabinetry that provides 
space to hold infant care items. The wheels or casters allow the 
bassinet to transport the infant throughout the care setting.
    (b) Classification. Class II (special controls). The device is 
exempt from the premarket notification procedures in subpart E of part 
807 of this chapter subject to Sec.  880.9. The special controls for 
this device are:
    (1) The manufacturer must conduct performance testing to determine 
material compatibility with cleansing products labeled to clean the 
device. Testing must demonstrate that the cleaning instructions 
provided by the manufacturer do not cause crazing, cracking, or 
deterioration of the device;
    (2) Manufacturers shall conduct performance testing to ensure the 
mechanical and structural stability of the bassinet under expected 
conditions of use, including transport of patients in the bassinet. 
Testing must demonstrate that failures such as wheel or caster breakage 
do not occur and that the device does not present a tipping hazard due 
to any mechanical failures under expected conditions of use; and
    (3) Each device must have the following label(s) affixed:
    (i) Adequate instructions for users to care for, maintain, and 
clean the bassinet; and
    (ii) A warning label on at least two sides of the plastic basket or 
bed component with the following language in text of at least 9 
millimeters in height:

WARNING: To avoid tipping hazards of this device, make sure that the 
basket or bed component sits firmly in the base and that all doors, 
drawers, and casters are secure.

    Dated: December 12, 2016.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2016-30193 Filed 12-16-16; 8:45 am]
 BILLING CODE 4164-01-P


