[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]


=======================================================================
-----------------------------------------------------------------------

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.

-----------------------------------------------------------------------

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, Pooja.Panigrahi@fda.hhs.gov.

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
------------------------------------------------------------------------
            Identified risks                   Mitigation measures
------------------------------------------------------------------------
Adverse tissue reaction................  Biocompatibility evaluation.
Infection..............................  Reprocessing validation and
                                          Labeling.
Implant malpositioning or migration....  Validation of technical
                                          specifications 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. 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


