Proposed Rules. Final amendment; final order

Agency: Food and Drug Administration, HHS
Action: Final amendment; final order
Citation: FR Doc. 2024-19882 · Docket No. FDA-2024-N-3970 · 21 CFR 886

Summary

The Food and Drug Administration (FDA, Agency, or we) is classifying the hydrophilic re-coating solution 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 hydrophilic re-coating solution'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 September 5, 2024. The classification was applicable on September 24, 2020.

Supplementary Information

I. Background Upon request, FDA has classified the hydrophilic re-coating solution as class II (special controls), which we have determined will provide a reasonable assurance of safety and effectiveness. 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 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 (see also part 860, subpart D (21 CFR part 860, subpart D)). 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 on 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 510(k) process, when necessary, to market their device. II. De Novo Classification On January 15, 2020, FDA received Tangible Science, Inc.'s request for De Novo classification of the Tangible Boost. 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 September 24, 2020, 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 886.5919. 1 We have named the generic type of device hydrophilic re-coating solution, and it is identified as a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components. 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. 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—Hydrophilic Re-Coating Solution Risks and Mitigation Measures Identified risks Mitigation measures Adverse events leading to eye irritation (redness, burning, stinging, discomfort, pain), infection, keratitis, corneal ulcer, loss of visual acuity, or allergic reaction Clinical performance testing, Human factors evaluation, and Labeling. Adverse tissue reaction Biocompatibility evaluation, Lens solution compatibility testing, Coating effectiveness testing, and Labeling. Infection Sterility testing and validation, Disinfection solution compatibility testing, Shelf life testing, and Labeling. Use error/improper device use leading to eye irritation (redness, burning, stinging, discomfort, pain), infection, keratitis, corneal ulcer, loss of visual acuity Clinical performance testing, Human factors evaluation, Coating performance 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. This device is subject to premarket notification requirements under section 510(k) of the FD&C Act. 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 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 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 part 801, regarding labeling, have been approved under OMB control number 0910-0485. List of Subjects in 21 CFR Part 886 Medical devices, Ophthalmic goods and services. Therefore, under the Federal Food, Drug, and Cosmetic Act and under authority delegated to the Commissioner of Food and Drugs, 21 CFR part 886 is amended as follows: PART 886—OPHTHALMIC DEVICES 1. The authority citation for part 886 continues to read as follows: Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371. 2. Add § 886.5919 to subpart F to read as follows: § 886.5919 Hydrophilic re-coating solution. (a) Identification. A hydrophilic re-coating solution is a home use device intended to restore the hydrophilic coating of rigid gas permeable (RGP) contact lenses using reactive coating components. (b) Classification. Class II (special controls). The special controls for this device are: (1) Clinical performance testing must evaluate device safety as assessed by adverse events, slit lamp findings, and maintenance of visual acuity. (2) The patient contacting components of the device and packaging components must be demonstrated to be biocompatible. (3) Performance testing must demonstrate the sterility of the device. (4) Use-related risk analysis must be performed to determine if a self-selection study and human factors validation study must be conducted to demonstrate that users can correctly use the device based solely on reading the directions for use. (5) Performance data must support the shelf life of the device by demonstrating continued sterility, package integrity, and device functionality over the identified shelf life. (6) Performance testing must demonstrate compatibility with each lens and solution labeled for use with the device. (7) Performance testing must demonstrate the ability of the device to restore the coating of compatible lenses. (8) Labeling must include the following: (i) Instructions on how to correctly use the device, including instructions to use fresh components for each use; (ii) Descriptions of compatible contact lenses; (iii) Descriptions of compatible care solutions; (iv) A warning that if patients are not sure of their lens material, they should contact their health care provider prior to use; and (v) A precaution against use with lenses that have not been demonstrated to be compatible with the device. Dated: August 29, 2024. Lauren K. Roth, Associate Commissioner for Policy. [FR Doc. 2024-19882 Filed 9-4-24; 8:45 am]