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Federal Register / Vol. 86, No. 233 / Wednesday, December 8, 2021 / Rules and Regulations
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Section 510m2 of the FD&C Act provides that FDA may exempt a device from 510k requirements on its own initiative, or upon petition of an interested person, if FDA determines that a 510k is not necessary to provide assurance of the safety and effectiveness of the device. This section requires FDA
to publish in the Federal Register a notice of intent to exempt a device, or of the petition, and to provide a 60-day period for public comment. Within 120
days after the issuance of the notice, FDA shall publish an order in the Federal Register setting forth the 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.
FDA classified powered patient transport devices into class II effective December 23, 1983 48 FR 53032, November 23, 1983. All powered patient transport devices were class II
devices regulated under 890.5150 21
CFR 890.5150, product code ILK. In 2013, FDA amended 890.5150 in response to a citizen petition requesting the Agency exempt permanently mounted stairway chair lifts from premarket notification requirements 78
FR 14015, March 4, 2013. In granting this request, FDA defined a subset of powered patient transport devices classified under new 890.5150a, identified as powered patient stairway chair lifts, product code PCD, and exempted this subset of devices from 510k premarket notification requirements provided certain conditions are met. The exemption did not affect all other powered patient transport devices identified under new 890.5150b, product code ILK. Under 890.5150b, a powered patient transport is a motorized device intended for use in mitigating 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 e.g., attendant-operated portable stairclimbing chairs. This generic type of device does not include motorized three-wheeled vehicles or wheelchairs.
II. Criteria for Exemption There are a number of factors FDA
may consider in order to determine whether a 510k is necessary to provide reasonable assurance of the safety and effectiveness of a class II device. FDA
generally considers the following factors to determine whether premarket notification is necessary: 1 The device does not have a significant history of false or misleading claims or risks
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associated with inherent characteristics of the device when making these determinations, FDA has considered the risks associated with false or misleading claims, and the frequency, persistence, cause or seriousness of the inherent risks 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 devices classification. FDA may also consider that, even when exempting devices, these devices would still be subject to the limitations on exemptions.
These factors are discussed in the guidance that the Agency issued on February 19, 1998, entitled Procedures for Class II Device Exemptions from Premarket Notification, Guidance for Industry and CDRH Staff Class II
510k Exemption Guidance. That guidance can be obtained through the internet at https www.fda.gov/
downloads/MedicalDevices/
DeviceRegulationandGuidance/
GuidanceDocuments/UCM080199.pdf or by sending an email request to CDRHGuidance@fda.hhs.gov to receive a copy of the document. Please use the document number 159 to identify the guidance you are requesting.
III. Petition On April 30, 2021, FDA received a petition requesting an exemption from premarket notification for powered patient transport, all other powered patient transport see Docket No. FDA
2021P0424. These devices are currently classified under 890.5150b, powered patient transport, all other powered patient transport. The classification regulation is split into paragraphs a and b with stairway chair lifts classified under 890.5150a product code PCD, exempt from premarket notification requirements provided certain conditions are met, while all other powered patient transport devices are classified in 890.5150b product code ILK and remain subject to premarket notification requirements. Importantly, many different devices are classified under the generic device-type within 890.5150b. The FDA review focused on all other powered patient transport devices identified under 890.5150b, and specifically, powered portable stair-

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climbing chairs as described in the petition see Docket No. FDA2021P
0424.
In the Federal Register of June 15, 2021 86 FR 31722, FDA published a notice announcing that this petition had been received and provided opportunity for interested persons to submit comments on the petition by August 16, 2021. In the Federal Register of June 30, 2021 86 FR 34770, FDA published a correction to the docket number, and, in the Federal Register of July 23, 2021 86
FR 39047, subsequently extended the opportunity to submit comments on the petition to August 30, 2021. FDA
received one comment that is unrelated to the petition and, thus, outside the scope of this final order.
FDA completed review of the petition and assessed the need for 510k clearance for this type of device against the criteria laid out in the Class II 510k Exemption Guidance. Based on this review, and for the reasons described in section IV, FDA has determined that premarket notification is necessary to provide a reasonable assurance of the safety and effectiveness of powered patient transport, all other powered patient transport, 890.5150b2
product code ILK. Accordingly, FDA
responded to the petition by letter dated October 19, 2021, denying the petition within the 180-day timeframe under section 510m2 of the FD&C Act see Docket No. FDA2021P0424.
IV. Order After reviewing the petition, FDA has determined that the petition failed to provide information to demonstrate that premarket notification is not necessary to provide reasonable assurance of the safety and effectiveness of the device.
FDA analyzed the petition against the criteria laid out in the Class II 510k Exemption Guidance.
A. The Device Does Not Have a Significant History of False or Misleading Claims or Risks Associated With Inherent Characteristics of the Device The petition included a 5-year look at FDA medical device reports MDRs, the FDA medical device recall database, and the FDA warning letter database using 890.5150, product code ILK and other product codes for other device classifications, which are listed as comparable device classifications to powered patient transport, all other powered patient transport. While FDA
does not have a concern related to the absence of warning letters or recalls nor, more generally, to a significant history of false or misleading claims, we do not agree that the use of the device is well
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