Rules and Regulations. Notice

Agency: Food and Drug Administration, HHS
Action: Notice
Citation: FR Doc. 2021-12505 · Docket No. FDA-2021-N-0493

Summary

The Food and Drug Administration (FDA or Agency) is announcing that it has received a petition requesting exemption from the premarket notification requirements for the generic device type, powered patient transport, all other powered patient transport. These devices are motorized devices used to mitigate mobility impairment caused by injury or other disease by moving a person from one location or level to another, such as up and down flights of stairs. This device type does not include motorized three-wheeled vehicles or wheelchairs, and is distinct from the device type, powered patient transport, powered patient stairway chair lifts, which is classified separately within the same regulation. FDA is publishing this notice to obtain comments in accordance with procedures established by the Federal Food, Drug, and Cosmetic Act (FD&C Act).

Dates

Submit either electronic or written comments by August 16, 2021.

Supplementary Information

I. Regulatory Background Under section 513 of the FD&C Act (21 U.S.C. 360c), FDA classifies devices into one of three regulatory classes: Class I, class II, or class III. FDA classification of a device is determined by the amount of regulation necessary to provide a reasonable assurance of safety and effectiveness. Pursuant to section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and the implementing regulations, part 807 (21 CFR part 807), persons who intend to market a new device are required to submit and obtain clearance of a premarket notification (510(k)) containing information that allows FDA to determine whether the new device is “substantially equivalent” within the meaning of section 513(i) of the FD&C Act to a legally marketed device that does not require premarket approval. On November 21, 1997, section 206 of the Food and Drug Administration Modernization Act (Pub. L. 105-115) added new section 510(m) to the FD&C Act. On December 13, 2016, section 3054 of the 21st Century Cures Act (Pub. L. 114-255) (Cures Act) amended section 510(m) of the FD&C Act. As amended, section 510(m)(1) of the FD&C Act requires FDA, within 90 days after enactment of the Cures Act and once every 5 years thereafter, to publish in the Federal Register a list of each type of class II device that does not require a report under section 510(k) of the FD&C Act to provide reasonable assurance of safety and effectiveness. As amended by the Cures Act, section 510(m)(2) of the FD&C Act provides that, 1 calendar day after the date of publication of the final list mentioned in section 510(m)(1)(B), FDA may exempt a class II device from the requirement to submit a report under section 510(k) of the FD&C Act, upon its own initiative or receipt of a petition from an interested person, if FDA determines that a report under section 510(k) is not necessary to assure the safety and effectiveness of the device. To do so, FDA must publish in the Federal Register notice of its intent to exempt the device, or the petition, and provide a 60-calendar day period for public comment. Within 120 days after the issuance of this notice, FDA must publish an order in the Federal Register that sets forth its final determination regarding the exemption of the device that was the subject of the notice. If FDA fails to respond to a petition under this section within 180 days of receiving it, the petition shall be deemed granted. The generic device type, powered patient transport is classified under § 890.5150 (21 CFR 890.5150). On March 4, 2013, in response to a petition, FDA created a separate classification for powered patient stairway chair lifts (§ 890.5150(a)), providing a conditional exemption from premarket notification for this device type, product code PCD (78 FR 14015). The classification change retained premarket notification requirements for all other powered patient transport, product code ILK (§ 890.5150(b)). II. Criteria for Exemption There are a number of factors FDA may consider to determine whether a 510(k) is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. These factors are discussed in the guidance the Agency issued on February 19, 1998, entitled “Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff” (available at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidance6Documents/UCM080199.pdf). As discussed in the guidance document, FDA generally considers the following factors to determine whether a report under section 510(k) is necessary for class II devices: (1) The device does not have a significant history of false or misleading claims or of risks associated with inherent characteristics of the device; (2) characteristics of the device necessary for its safe and effective performance are well established; (3) changes in the device that could affect safety and effectiveness will either (a) be readily detectable by users by visual examination or other means such as routine testing, before causing harm or (b) not materially increase the risk of injury, incorrect diagnosis, or ineffective treatment; and (4) any changes to the device would not be likely to result in a change in the device's classification. FDA may also consider that, even when exempting devices, these devices would still be subject to the general limitations on exemptions. III. Proposed Class II Device Exemptions FDA has received the following petition requesting an exemption from premarket notification for a class II device: Sam DeMarco, Staff Regulatory Affairs Specialist, on behalf of Stryker Medical, 3800 E Centre Ave., Portage, MI 49002, for powered patient transport, all other powered patient transport, classified under § 890.5150(b). FDA seeks comment on the petition in accordance with section 510(m)(2) of the FD&C Act. IV. Paperwork Reduction Act of 1995 While this notice contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (44 U.S.C. 3501-3521) is not required for this notice. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in part 807, subpart E, regarding premarket notification submissions, have been approved under OMB control number 0910-0120. Dated: June 7, 2021. Lauren K. Roth, Acting Principal Associate Commissioner for Policy. [FR Doc. 2021-12505 Filed 6-14-21; 8:45 am]