[Federal Register Volume 88, Number 3 (Thursday, January 5, 2023)]
[Rules and Regulations]
[Pages 753-755]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-28601]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 888

[Docket No. FDA-2022-N-3191]


Medical Devices; Orthopedic Devices; Classification of the Bone 
Indentation Device

AGENCY: Food and Drug Administration, HHS.

ACTION: Final amendment; final order.

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SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is 
classifying the bone indentation device into class II (special 
controls). The special controls that apply to the device type are 
identified in this order and will be part of the codified language for 
the bone indentation device's classification. We are taking this action 
because we have determined that classifying the device into class II 
(special controls) will provide a reasonable assurance of safety and 
effectiveness of the device. We believe this action will also enhance 
patients' access to beneficial innovative devices.

DATES: This order is effective January 5, 2023. The classification was 
applicable on August 19, 2021.

FOR FURTHER INFORMATION CONTACT: Laura Rose, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 4435, Silver Spring, MD 20993-0002, 301-348-1947, 
[email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    Upon request, FDA has classified the bone indentation device as 
class II (special controls), which we have determined will provide a 
reasonable assurance of safety and effectiveness. In addition, we 
believe this action will enhance patients' access to beneficial 
innovation, in part by placing the device into a lower device class 
than the automatic class III assignment.
    The automatic assignment of class III occurs by operation of law 
and without any action by FDA, regardless of the level of risk posed by 
the new device. Any device that was not in commercial distribution 
before May 28, 1976, is automatically classified as, and remains 
within, class III and requires premarket approval unless and until FDA 
takes an action to classify or reclassify the device (see 21 U.S.C. 
360c(f)(1)). We refer to these devices as ``postamendments devices'' 
because they were not in

[[Page 754]]

commercial distribution prior to the date of enactment of the Medical 
Device Amendments of 1976, which amended the Federal Food, Drug, and 
Cosmetic Act (FD&C Act).
    FDA may take a variety of actions in appropriate circumstances to 
classify or reclassify a device into class I or II. We may issue an 
order finding a new device to be substantially equivalent under section 
513(i) of the FD&C Act (see 21 U.S.C. 360c(i)) to a predicate device 
that does not require premarket approval. We determine whether a new 
device is substantially equivalent to a predicate device by means of 
the procedures for premarket notification under section 510(k) of the 
FD&C Act (21 U.S.C. 360(k)) and part 807 (21 CFR part 807).
    FDA may also classify a device through ``De Novo'' classification, 
a common name for the process authorized under section 513(f)(2) of the 
FD&C Act. Section 207 of the Food and Drug Administration Modernization 
Act of 1997 (Pub. L. 105-115) established the first procedure for De 
Novo classification. Section 607 of the Food and Drug Administration 
Safety and Innovation Act (Pub. L. 112-144) modified the De Novo 
application process by adding a second procedure. A device sponsor may 
utilize either procedure for De Novo classification.
    Under the first procedure, the person submits a 510(k) for a device 
that has not previously been classified. After receiving an order from 
FDA classifying the device into class III under section 513(f)(1) of 
the FD&C Act, the person then requests a classification under section 
513(f)(2).
    Under the second procedure, rather than first submitting a 510(k) 
and then a request for classification, if the person determines that 
there is no legally marketed device upon which to base a determination 
of substantial equivalence, that person requests a classification under 
section 513(f)(2) of the FD&C Act.
    Under either procedure for De Novo classification, FDA is required 
to classify the device by written order within 120 days. The 
classification will be according to the criteria under section 
513(a)(1) of the FD&C Act. Although the device was automatically placed 
within class III, the De Novo classification is considered to be the 
initial classification of the device.
    When FDA classifies a device into class I or II via the De Novo 
process, the device can serve as a predicate for future devices of that 
type, including for 510(k)s (see section 513(f)(2)(B)(i) of the FD&C 
Act). As a result, other device sponsors do not have to submit a De 
Novo request or premarket approval application to market a 
substantially equivalent device (see section 513(i) of the FD&C Act, 
defining ``substantial equivalence''). Instead, sponsors can use the 
less-burdensome 510(k) process, when necessary, to market their device.

II. De Novo Classification

    On March 31, 2021, FDA received Active Life Scientific's request 
for De Novo classification of the OsteoProbe. FDA reviewed the request 
in order to classify the device under the criteria for classification 
set forth in section 513(a)(1) of the FD&C Act.
    We classify devices into class II if general controls by themselves 
are insufficient to provide reasonable assurance of safety and 
effectiveness, but there is sufficient information to establish special 
controls that, in combination with the general controls, provide 
reasonable assurance of the safety and effectiveness of the device for 
its intended use (see 21 U.S.C. 360c(a)(1)(B)). After review of the 
information submitted in the request, we determined that the device can 
be classified into class II with the establishment of special controls. 
FDA has determined that these special controls, in addition to the 
general controls, will provide reasonable assurance of the safety and 
effectiveness of the device.
    Therefore, on August 19, 2021, FDA issued an order to the requester 
classifying the device into class II. In this final order, FDA is 
codifying the classification of the device by adding 21 CFR 
888.1600.\1\ We have named the generic type of device bone indentation 
device, and it is identified as a device that measures resistance to 
indentation in bone.
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    \1\ FDA notes that the ``ACTION'' caption for this final order 
is styled as ``Final amendment; final order,'' rather than ``Final 
order.'' Beginning in December 2019, this editorial change was made 
to indicate that the document ``amends'' the Code of Federal 
Regulations. The change was made in accordance with the Office of 
Federal Register's (OFR) interpretations of the Federal Register Act 
(44 U.S.C. chapter 15), its implementing regulations (1 CFR 5.9 and 
parts 21 and 22), and the Document Drafting Handbook.
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    FDA has identified the following risks to health associated 
specifically with this type of device and the measures required to 
mitigate these risks in table 1.

     Table 1--Bone Indentation Device Risks and Mitigation Measures
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          Identified risks                    Mitigation measures
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Bone fracture or soft tissue damage.  In vivo performance testing, and
                                       Labeling.
Adverse tissue reaction.............  Biocompatibility evaluation.
Infection, including operator         Shelf-life testing, Sterilization
 exposure to infectious transmission.  validation, Reprocessing
                                       validation, Human factors
                                       testing, and Labeling.
Patient or operator injury due to     Electrical safety testing, and
 electrical hazards.                   Electromagnetic compatibility
                                       testing.
Pain, discomfort, bruising, or        In vivo performance testing, and
 bleeding.                             Labeling.
Inappropriate patient management due  Non-clinical performance testing,
 to inaccurate device output or       In vivo performance testing,
 misinterpretation of device output.  Software verification, validation,
                                       and hazard analysis,
                                      Human factors testing, and
                                       Labeling.
------------------------------------------------------------------------

    FDA has determined that special controls, in combination with the 
general controls, address these risks to health and provide reasonable 
assurance of safety and effectiveness. For a device to fall within this 
classification, and thus avoid automatic classification in class III, 
it would have to comply with the special controls named in this final 
order. The necessary special controls appear in the regulation codified 
by this order. We encourage sponsors to consult with us if they wish to 
use a non-animal testing method they believe is suitable, adequate, 
validated, and feasible. We will consider if such an alternative method 
could be assessed for equivalency to an animal test method. This device 
is subject to premarket notification requirements under section 510(k) 
of the FD&C Act.

[[Page 755]]

III. 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.

IV. Paperwork Reduction Act of 1995

    This final order establishes special controls that refer to 
previously approved collections of information found in other FDA 
regulations and guidance. 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. 3501-3521). The collections 
of information in 21 CFR part 860, subpart D, regarding De Novo 
classification have been approved under OMB control number 0910-0844; 
the collections of information in 21 CFR part 814, subparts A through 
E, regarding premarket approval, have been approved under OMB control 
number 0910-0231; the collections of information in part 807, subpart 
E, regarding premarket notification submissions, have been approved 
under OMB control number 0910-0120; the collections of information in 
21 CFR part 820, regarding quality system regulation, have been 
approved under OMB control number 0910-0073; and the collections of 
information in 21 CFR parts 801, regarding labeling, have been approved 
under OMB control number 0910-0485.

List of Subjects in 21 CFR Part 888

    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 
888 is amended as follows:

PART 888--ORTHOPEDIC DEVICES

0
1. The authority citation for part 888 continues to read as follows:

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


0
2. Add Sec.  888.1600 to subpart B to read as follows:


Sec.  888.1600  Bone indentation device.

    (a) Identification. A bone indentation device is a device that 
measures resistance to indentation in bone.
    (b) Classification. Class II (special controls). The special 
controls for this device are:
    (1) In vivo performance testing must demonstrate that the device 
performs as intended under anticipated conditions of use. Testing must 
evaluate the risk of bone fracture, soft tissue damage, pain, 
discomfort, bruising, or bleeding.
    (2) Non-clinical performance testing must demonstrate that the 
device performs as intended under anticipated conditions of use, 
including an evaluation of the accuracy and precision of the device 
with respect to resistance to bone indentation.
    (3) Human factors testing must demonstrate that the intended 
user(s) can correctly use the device, based on the instructions for 
use.
    (4) The patient-contacting components of the device must be 
demonstrated to be biocompatible.
    (5) Performance testing must demonstrate:
    (i) The sterility of the patient-contacting components of the 
device; and
    (ii) Validation of reprocessing instructions for any reusable 
components of the device.
    (6) Performance data must support the shelf life of the device by 
demonstrating continued sterility and device functionality over the 
identified shelf life.
    (7) Software verification, validation, and hazard analysis must be 
performed.
    (8) Performance data must be provided to demonstrate the 
electromagnetic compatibility (EMC) and electrical safety of the 
device.
    (9) Labeling must include:
    (i) Instructions for use;
    (ii) Validated methods and instructions for reprocessing of any 
reusable components;
    (iii) A shelf life for any sterile components;
    (iv) Information regarding limitations of the clinical significance 
of the device output; and
    (v) A detailed summary of the accuracy and precision of the device.

    Dated: December 29, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-28601 Filed 1-4-23; 8:45 am]
BILLING CODE 4164-01-P


