
[Federal Register Volume 80, Number 157 (Friday, August 14, 2015)]
[Notices]
[Pages 48868-48869]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-20005]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2014-D-0967]


Intent To Exempt Certain Unclassified, Class II, and Class I 
Reserved Medical Devices From Premarket Notification Requirements; 
Guidance for Industry and Food and Drug Administration Staff; 
Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
availability of a guidance entitled ``Intent to Exempt Certain 
Unclassified, Class II, and Class I Reserved Medical Devices from 
Premarket Notification Requirements,'' which updates an earlier 
guidance of the same title published in the Federal Register on July 1, 
2015. This guidance describes FDA's intent to exempt certain 
unclassified medical devices (that FDA intends to classify into class I 
or II), certain class II medical devices, and certain class I medical 
devices from premarket notification requirements. Due to an 
administrative error, certain comments to this Docket were not 
considered prior to the July 1, 2015, guidance publication. These 
comments have now been considered. FDA believes additional devices and 
product codes are sufficiently well understood and do not require 
premarket notification to assure their safety and effectiveness. As 
such, FDA is updating and adding these to the guidance.

DATES: Submit either electronic or written comments on this guidance at 
any time. General comments on Agency guidance documents are welcome at 
any time.

ADDRESSES: An electronic copy of the guidance document is available for 
download from the Internet. See the SUPPLEMENTARY INFORMATION section 
for information on electronic access to the guidance. Submit written 
requests for a single hard copy of the guidance document entitled 
``Intent to Exempt Certain Unclassified, Class II, and Class I Reserved 
Medical Devices from Premarket Notification Requirements'' to the 
Office of the Center Director, Guidance and Policy Development, Center 
for Devices and Radiological Health, Food and Drug Administration, 
10903 New Hampshire Ave., Bldg. 66, Rm. 5431, Silver Spring, MD 20993-
0002. Send one self-addressed adhesive label to assist that office in 
processing your request.
    Submit electronic comments on the guidance to http://www.regulations.gov. Submit written comments to the Division of Dockets 
Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, 
Rm. 1061, Rockville, MD 20852. Identify comments with the docket number 
found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Angela C. Krueger, Center for Devices 
and Radiological Health, Food and Drug Administration, 10903 New 
Hampshire Ave., Bldg. 66, Rm. 1666, Silver Spring, MD 20993-0002, 301-
796-6380.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the commitment letter (section 1.G of the Performance Goals and 
Procedures) that was drafted as part of the reauthorization process for 
the Medical Device User Fee Amendments of 2012, part of the Food and 
Drug Administration Safety and Innovation Act (Pub. L. 112-144), FDA 
committed to identifying low-risk medical devices to exempt from 
premarket notification requirements. This guidance describes FDA's 
intent to exempt certain unclassified medical devices (that FDA intends 
to classify into class I or II), certain class II medical devices, and 
certain class I medical devices (that no longer meet the ``reserved'' 
criteria in section 510(l) of the Federal Food, Drug, and Cosmetic Act 
(21 U.S.C. 360(l))) from premarket notification requirements. FDA 
believes the devices and product codes being added to this guidance 
document are sufficiently well understood and do not require 510(k) 
notification to assure their safety and effectiveness.
    The draft of this guidance was made available in the Federal 
Register on August 1, 2014 (79 FR 44804). The comment period closed on 
September 30, 2014. FDA received 55 sets of comments on the draft 
guidance. FDA published a final guidance on July 1, 2015 (80 FR 37633). 
However, due to an administrative error, certain comments were not 
considered prior to the July 1, 2015, guidance publication. These 
comments have now been considered, and, based on that review, FDA is 
updating and adding certain devices and product codes to the guidance.
    These comments requested that FDA include approximately 390 
additional product codes in the guidance. Of these product codes, more 
than 110 were ones regulated by the Office of In Vitro Diagnostics and 
Radiological Health, which were outside of the scope of FDA's review to 
identify low-risk devices to ultimately exempt from premarket 
notification requirements. Additionally, for approximately 75 of the 
product codes, the comments noted that additional controls, such as 
conformance to recognized standards, would be necessary if 510(k)s were 
not submitted for these devices. Because the imposition of such 
controls would go beyond the scope of this guidance, FDA is not adding 
these device types and product codes to the guidance.
    The comments also requested the addition of 18 product codes to the 
guidance that were either already in the final guidance published on 
July 1, 2015, exempt from premarket notification, or for which FDA is 
currently exercising enforcement discretion (Ref. 1). For example, more 
than 30 comments spoke to the inclusion of product code NUQ (Pad, 
Menstrual, Reusable), which was included in the draft guidance 
document, and remained in the final guidance document issued July 1, 
2015.
    FDA has considered the remaining product codes proposed in the 
comments and has determined that the following eight additional product 
codes should be included in the guidance document: Product code DTL, 
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass (see 21 
CFR 870.4290--Cardiopulmonary bypass adaptor, stopcock, manifold, or 
fitting); product code OCY, Endoscopic Guidewire, Gastroenterology-
urology (see 21 CFR 876.1500--Endoscope and accessories); product code 
KOE, Dilator, urethral (see 21 CFR 876.5520--Urethral dilator); product 
code FTA, Light, Surgical, Accessories (see 21 CFR 878.4580--Surgical 
lamp); product code GZM, Analyzer, Rigidity (see 21 CFR 882.1020--
Rigidity analyzer); product code GZO, Device, Galvanic Skin Response 
Measurement (see 21 CFR 882.1540--Galvanic skin response measurement 
device); product code HCJ, Device, Skin Potential Measurement (see 21 
CFR 882.1560--Skin potential measurement device);

[[Page 48869]]

and product code HLJ, Ophthalmoscope, Battery-powered (see 21 CFR 
886.1570--Ophthalmoscope). FDA has determined it is appropriate to add 
these product codes to the guidance because FDA has tentatively 
concluded they are sufficiently well understood and do not require 
premarket notification (510(k)) to assure their safety and 
effectiveness.
    Seven comments also requested the removal or clarification of 
specific product codes in the draft guidance. The issues raised in 
these comments were addressed by the removal of certain product codes 
from the draft guidance, and the clarification of two product codes: 
Product code MRQ, Analyzer, Nitrogen Dioxide; and product code KKX, 
Drape, Surgical. Moreover, in response to the issues raised, FDA is 
clarifying that it is not the Agency's intent to exempt combination 
products or single entity products containing antimicrobial agents. For 
the remaining product codes identified in those comments, FDA believes 
that the product codes are sufficiently well understood and do not 
require premarket notification (510(k)) to assure their safety and 
effectiveness. Thus, FDA has not removed these products codes from the 
guidance.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
current thinking of FDA on the intent to exempt certain unclassified, 
class II, and class I reserved medical devices from premarket 
notification requirements. It does not establish any rights for any 
person and is not binding on FDA or the public. You can use an 
alternative approach if it satisfies the requirements of the applicable 
statutes and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
downloading an electronic copy from the Internet. A search capability 
for all Center for Devices and Radiological Health guidance documents 
is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm. Guidance 
documents are also available at http://www.regulations.gov. Persons 
unable to download an electronic copy of ``Intent to Exempt Certain 
Unclassified, Class II, and Class I Reserved Medical Devices from 
Premarket Notification Requirements'' may send an email request to 
CDRH-Guidance@fda.hhs.gov to receive an electronic copy of the 
document. Please use the document number 1300046 to identify the 
guidance you are requesting.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807, subpart E, have been 
approved under OMB control number 0910-0120.

V. Comments

    Interested persons may submit either electronic comments regarding 
this document to http://www.regulations.gov or written comments to the 
Division of Dockets Management (see ADDRESSES). It is only necessary to 
send one set of comments. Identify comments with the docket number 
found in brackets in the heading of this document. Received comments 
may be seen in the Division of Dockets Management between 9 a.m. and 4 
p.m., Monday through Friday, and will be posted to the docket at http://www.regulations.gov.

VI. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site addresses in this reference section, but 
we are not responsible for any subsequent changes to the Web sites 
after this document publishes in the Federal Register.)
    1. FDA announced that it would exercise enforcement discretion for 
premarket notification for the following product codes, among others, 
if the devices meet the criteria set forth in guidance: OFX, OKF, OKG, 
OKH, OKI, LRO, and OJW. See Convenience Kits Interim Regulatory 
Guidance (May 1997), available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080217.pdf.

    Dated: August 10, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-20005 Filed 8-13-15; 8:45 am]
BILLING CODE 4164-01-P


