2019-23307. 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, [e-mail].

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.

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

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

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

2. Add § 888.4505 to subpart E to read as follows:

§ 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.