Medical devices can be used in a variety of settings and now there’s FDA guidance for home use devices. Titled “Design Considerations for Devices Intended for Home Use – Guidance for Industry and Food and Drug Administration Staff,” the new release replaces the draft document issued in 2012. It is intended to help manufacturers address the unique risks associated with user interactions by non-professionals in homes.
The guidance was deemed necessary due to the rise in folks using medical devices outside of professional health care facilities. The growth of the home medical care industry, with more patients with chronic illnesses living in home settings, means that home use devices are increasingly in demand.
So this guidance was developed specifically to review the risks associated with devices in the home setting, with considerations specifically developed to minimize those risks. The FDA is letting you know that you’ll be expected to demonstrate the safety of your home use device as part of your submission data. And what better time for you to address these issues than in the design phase?
What kind of issues will the FDA be looking at? Here’s a general review:
- Environmental considerations (examples are location, contaminants, water supply, air flow, travel, and so on)
- User considerations (physical, perceptual, cognitive, emotional)
- Design considerations (lock-out mechanisms, maintenance, calibration, mechanical, electrical)
- Human factors (user training, certification)
- Labeling (emergency handling, disposal, hygiene)
- Post market considerations (customer service, device reporting)
Appendix 1 covers a list of references, including various standards that are mentioned in the guidance document. Appendix 2 covers additional resources. Many of these references include websites for the document or organization listed.
Of course, you’ll need a copy of the guidance document itself. There’s a number of resources, but you may want to rely on Document Center for your purchase. Why? Because Document Center tracks the publications we sell and provides you with a no-charge notification when any of your documents are updated. If you’d been using the 2012 draft of this item, you’d have gotten your notification within a week of the release of the new update.
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