[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.
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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