Stryker Petition Pushes FDA to Exempt Powered Wheel Stretchers From 510(k) Requirements
The US Food and Drug Administration (FDA) on Monday issued a final order exempting powered wheeled stretchers from premarket notification (510(k)) requirements in response to a citizen petition filed by Stryker Medical last July.The agency previously exempted certain products under five different product codes from premarket notification requirements in October. In 2017, FDA finalized an order exempting 1,003 types of Class II devices from premarket notification requirements.
After reviewing the petition and its own Class II 510(k) exemption guidance, FDA says it determined that premarket notification “is not necessary to assure the safety and effectiveness of the device, as long as certain conditions are met.”
FDA says the device’s risks and performance characteristics are “well established” and that changes to the device that “could affect safety and effectiveness will be readily detectable by visual examination.”
Under the order, FDA says powered wheeled stretchers, marketed under product code INK, will qualify for exemption from premarket notification requirements so long as companies conduct a series of analyses and nonclinical testing and ensure the device is adequately labeled.
Specifically, FDA says companies should conduct testing and analyses to show that the device has adequate safety controls and can prevent falls; support its rated user weight load; and last through its expected service life.
Additional testing and analyses should be conducted to demonstrate electromagnetic compatibility and electrical safety; biocompatibility for skin-contacting components; software validation; and battery performance.
FDA also says that a dimensional risk assessment should be conducted to reduce the risk of patient entrapment and refers companies to its 2016 guidance, Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment.
FDA notes that many of the conditions for exemption from premarket notification are drawn from FDA-recognized consensus standards and provides a list of the relevant standards.
Federal Register Notice