Source: https://www.federalregister.gov/documents/2013/03/04/2013-04897/medical-devices-exemption-from-premarket-notification-class-ii-devices-powered-patient-transport
Timestamp: 2017-11-23 05:45:58
Document Index: 422463633

Matched Legal Cases: ['art 807', '§\u2009890', '§\u2009890', '§\u2009890', 'art 1', '§\u2009890', 'art 807', '§\u2009890']

Federal Register :: Medical Devices; Exemption From Premarket Notification; Class II Devices; Powered Patient Transport
78 FR 14015
14015-14017 (3 pages)
https://www.federalregister.gov/d/2013-04897 https://www.federalregister.gov/d/2013-04897
Section 510(k) of the FD&C Act (21 U.S.C. 360(k)) and its implementing regulations (21 CFR part 807) require persons who propose to begin the introduction or delivery for introduction into interstate commerce for commercial distribution of a device intended for human use to submit a 510(k) to FDA. The device may not be marketed until Start Printed Page 14016FDA finds it “substantially equivalent” within the meaning of section 513(i) of the FD&C Act (21 U.S.C. 360c(i)) to a legally marketed device that does not require premarket approval.
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 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 510(k) Exemption Guidance). That guidance can be obtained through the Internet on the Center for Devices and Radiological Health home page at http://www.fda.gov/​MedicalDevices/​DeviceRegulationandGuidance/​GuidanceDocuments/​ucm080198.htm or by sending an email request to dsmica@fda.hhs.gov to receive an electronic copy of the document or send a fax request to 301-847-8149 to receive a hard copy. Please use the document number 159 to identify the guidance you are requesting.
On November 7, 2011, FDA received a petition requesting an exemption from premarket notification for powered patient transport devices commonly known as stairlifts. (See Docket No. FDA-2011-P-0804.) These devices are currently classified under § 890.5150 (21 CFR 890.5150), Powered patient transport. On May 3, 2012, FDA responded to the petition with a letter explaining that the information provided in the petition was insufficient for the Agency to assess whether the risks posed by this type of device could be sufficiently mitigated in the absence of premarket notification requirements. To address the Agency's concerns, the petitioner submitted additional information regarding standards that could be relied upon to mitigate the device risks, which the Agency received on June 19, 2012. This restarted the 180-day clock under section 510(m)(2) of the FD&C Act. (See Class II 510(k) Exemption Guidance, p. 3.)
In the Federal Register of June 1, 2012 (77 FR 32642), FDA published a notice announcing that this petition had been received and provided opportunity for interested persons to submit comments on the petition by July 2, 2012. FDA received one comment supporting an exemption from premarket notification for this type of device. The comment stated that these devices have been produced for many years and have a very good safety record. It noted that all of these products already need to comply with the FDA-recognized American Society of Mechanical Engineers (ASME) standard “ASME A18.1 Safety Standard for Platform Lifts and Stairway Chairlifts” (ASME A18.1), which provides that these products are to be built and certified to the provisions of the National Electric Code and the Canadian Standards Association (CSA)/ASME standard “CSA B44.1/ASME A17.5 Elevator and Escalator Electrical Equipment” for elevator and escalator equipment.
For clarity, this order: (1) Defines a subset of powered patient transport devices classified under § 890.5150 identified as “powered patient stairway chair lifts,” and (2) exempts this subset of devices from premarket notification requirements provided certain conditions are met, which will be codified in this classification regulation. This order does not affect other devices classified under § 890.5150, such as attendant-operated portable stair-climbing chairs (which are different from wheelchairs), which remain subject to premarket notification requirements, and does not change the class of any of the devices classified under this regulation, which all remain in class II. These devices will remain subject to current good manufacturing practices requirements and other general controls under the statute.
This final order provides conditions for exemption from premarket notification on appropriate testing and labeling of the device. The following conditions must be met for the device to be 510(k)-exempt: (1) Appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must demonstrate that the safety controls are adequate to prevent a free fall of the chair in the event of a device failure; (2) appropriate analysis and nonclinical testing must demonstrate the ability of the device, including armrests, to withstand the rated load with an appropriate factor of safety; (3) appropriate restraints must be provided to prevent the user from falling from the device (such as that outlined in the currently FDA-recognized edition of ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”); (4) appropriate analysis and nonclinical testing (such as that outlined in the currently FDA-Start Printed Page 14017recognized edition of AAMI/ANSI/IEC 60601-1-2, “Medical Electrical Equipment—Part 1-2: General Requirements for Safety—Collateral Standard: Electromagnetic Compatibility—Requirements and Tests,” and ASME A18.1 “Safety Standard for Platform Lifts and Stairway Chair Lifts”) must validate electromagnetic compatibility and electrical safety; and (5) appropriate analysis and nonclinical testing must demonstrate the resistance of the device upholstery to ignition.
Firms are now exempt from 510(k) requirements for stairway chair lifts as long as they meet these conditions of exemption. Firms must comply with the particular mitigation measures set forth in the conditions for exemption or submit and receive clearance for a 510(k) prior to marketing.
§ 890.5150
(2) Classification. Class II. The stairway chair lift is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 890.9 and the following conditions for exemption: