[Federal Register Volume 84, Number 207 (Friday, October 25, 2019)]
[Rules and Regulations]
[Pages 57320-57321]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23307]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 888
[Docket No. FDA-2019-N-2711]
Medical Devices; Orthopedic Devices; Classification of Orthopedic
Surgical Instrumentation Designed for Osteochondral Implants With
Press-Fit Fixation
AGENCY: Food and Drug Administration, HHS.
ACTION: Final order.
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SUMMARY: The Food and Drug Administration (FDA or we) is classifying
the orthopedic surgical instrumentation designed for osteochondral
implants with press-fit fixation 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 orthopedic
surgical instrumentation designed for osteochondral implants with
press-fit fixation'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, in part by reducing
regulatory burdens.
DATES: This order is effective October 25, 2019. The classification was
applicable on April 26, 2018.
FOR FURTHER INFORMATION CONTACT: Pooja Panigrahi, Center for Devices
and Radiological Health, Food and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1449, Silver Spring, MD 20993-0002, 240-
402-1090, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
Upon request, FDA has classified the orthopedic surgical
instrumentation designed for osteochondral implants with press-fit
fixation as class II (special controls), which we have determined will
provide a reasonable assurance of safety and effectiveness for its
intended use. In addition, we believe this action will enhance
patients' access to beneficial innovation, in part by reducing
regulatory burdens by placing the device into the appropriate device
class based on risk and the regulatory controls sufficient to provide
reasonable assurance of safety and effectiveness.
FDA may classify a device through an accessory classification
request under section 513(f)(6) of the Federal Food, Drug, and Cosmetic
Act (FD&C Act) (21 U.S.C. 360c(f)(6)), established by section 707 of
the FDA Reauthorization Act of 2017 (Pub. L. 115-52). The provision
allows manufacturers or importers to request classification of an
accessory distinct from another device upon written request. The
classification is based upon the risks of the accessory when used as
intended as well as the level of regulatory controls necessary to
provide a reasonable assurance of safety and effectiveness,
notwithstanding the classification of any other device with which such
accessory is intended to be used. Until an accessory is reclassified by
FDA, the classification of any accessory distinct from another device
by regulation or written order issued prior to December 13, 2016, will
continue to apply.
Under section 513(f)(6)(D)(ii) of the FD&C Act, a manufacturer or
importer may request appropriate classification of an accessory that
has been granted marketing authorization as part of a premarket
approval application (PMA), premarket notification (510(k)), or De Novo
classification request. FDA must grant or deny the request not later
than 85 days after receipt and, if granting, publish a notice in the
Federal Register within 30 days announcing the classification.
Alternatively, under section 513(f)(6)(C), a person filing a PMA or
510(k) may include a written request for the proper classification of
an accessory that has not been classified distinctly from another
device based on the risks of the accessory when used as intended and
the level of regulatory controls necessary to provide a reasonable
assurance of safety and effectiveness. When the written request is
included in a submission for marketing authorization, FDA must grant or
deny the request along with the response to the PMA or 510(k). Upon
granting, FDA will publish a notice in the Federal Register within 30
days announcing the classification.
II. Accessory Classification
On January 31, 2018, Cartiva, Inc., submitted a request for
accessory classification of the Reusable Implantation Instruments for
the Cartiva Synthetic Cartilage Implant. 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 April 26, 2018, FDA issued an order to the requester
classifying the device into class II. FDA is codifying the
classification of the device by adding 21 CFR 888.4505. We have named
the generic type of device orthopedic surgical instrumentation designed
for osteochondral implants with press-fit fixation, and it is
identified as hand-held devices intended to manipulate bone and
cartilage tissue or the implant for the positioning, alignment, defect
creation, and placement of press-fit osteochondral implants that
utilize no additional means of fixation (e.g., suture fixation,
adhesives). This type of device includes instruments specific to the
geometry of the implant.
[[Page 57321]]
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--Orthopedic Surgical Instrumentation Designed for Osteochondral
Implants With Press-Fit Fixation Risks and Mitigation Measures
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Identified risks Mitigation measures
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Adverse tissue reaction................ Biocompatibility evaluation.
Infection.............................. Reprocessing validation and
Labeling.
Implant malpositioning or migration.... Validation of technical
specifications 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. In order 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.
Section 510(m)(2) of the FD&C Act provides that FDA may exempt a
class II device from the premarket notification requirements under
section 510(k) if, after notice of our intent to exempt and
consideration of comments, we determine by order that premarket
notification is not necessary to provide reasonable assurance of safety
and effectiveness of the device. We believe this may be such a device.
The notice of intent to exempt the device from premarket notification
requirements is published elsewhere in this issue of the Federal
Register.
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 the guidance document ``De Novo Classification
Process (Evaluation of Automatic Class III Designation)'' have been
approved under OMB control number 0910-0844; the collections of
information in the guidance document ``Medical Device Accessories--
Describing Accessories and Classification Pathways'' have been approved
under OMB control number 0910-0823; the collections of information in
part 814, subparts A through E, regarding premarket approval, have been
approved under OMB control number 0910-0231; the collections of
information in part 820, regarding current good manufacturing
practices, have been approved under OMB control number 0910-0073; the
collections of information in part 807, subpart E, regarding premarket
notification submissions, have been approved under OMB control number
0910-0120; and the collections of information in part 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. 888.4505 to subpart E to read as follows:
Sec. 888.4505 Orthopedic surgical instrumentation designed for
osteochondral implants with press-fit fixation.
(a) Identification. Orthopedic surgical instruments designed for
osteochondral implants with press-fit fixation are hand-held devices
intended to manipulate bone and cartilage tissue or the implant for the
positioning, alignment, defect creation, and placement of press-fit
osteochondral implants that utilize no additional means of fixation
(e.g., suture fixation, adhesives). This type of device includes
instruments specific to the geometry of the implant.
(b) Classification. Class II (special controls). The special
controls for this device are:
(1) Technical specifications regarding geometry of the instruments
must be specified and validated to demonstrate that the instruments can
safely position and place the implant.
(2) The patient contacting components of the device must be
demonstrated to be biocompatible.
(3) Labeling must include:
(i) Identification of implant(s) and instruments which have been
validated for use together; and
(ii) Validated methods and instructions for reprocessing any
reusable parts.
Dated: October 21, 2019.
Lowell J. Schiller,
Principal Associate Commissioner for Policy.
[FR Doc. 2019-23307 Filed 10-24-19; 8:45 am]
BILLING CODE 4164-01-P