New FDA guidance on home use medical devices

December 21, 2012 by MassDevice

Global Medicine

By Stewart Eisenhart, Emergo Group

New guidance published by the US Food and Drug Administration advises manufacturers of "home use" medical devices on how to ensure compliance with safety and effectiveness requirements when designing their products.

The guidance applies to both prescription and over-the-counter devices intended for users or patients outside of clinical or professional settings. Use of such devices has become more and more prevalent in the US healthcare market, prompting new recommendations from the FDA.

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Design control recommendations
Among medical device design controls required under 21 CFR Part 820, the guidance highlights risk management processes as particularly important to home-use device manufacturers. If a home-use device includes a software component, the manufacturer should ensure that its risk management process covers performance, error detection and control issues as well.

Environmental factors
Home-use device design must take into account environmental factors that could compromise safety or effectiveness, according to the FDA guidance. Environmental issues manufacturers should bear in mind include:

Location: where will the device intended to be used, and how will different settings affect safety and effectiveness?

Dampness/humidity: how do variable humidity levels impact the device’s functionality?

Physical location: do different physical structures affect the device’s intended use?