Medtech Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Home-Use Meeting: Device Definition Should Include Wireless Products

This article was originally published in The Gray Sheet

Executive Summary

CDRH's efforts to better target its oversight for products principally used in patients' homes are raising fundamental regulatory questions like, "what is a medical device?

You may also be interested in...



Home-Use Device Guidance Outlines Design, Labeling Considerations

Design of devices for home use should take into account the “large range of physical, sensory, cognitive and emotional capabilities and disabilities” home users may have, the FDA draft document recommends. Comments are due March 12.

Devices In The Home: FDA Panel Explores New Ways To Provide Instructions

As medical devices move out of the hands of trained health professionals and into the home, FDA and manufacturers need to find new ways to teach people how to use them safely, according to agency advisors.

Devices In The Home: FDA Panel Explores New Ways To Provide Instructions

As medical devices move out of the hands of trained health professionals and into the home, FDA and manufacturers need to find new ways to teach people how to use them safely, according to agency advisors.

Related Content

Topics

UsernamePublicRestriction

Register

MT028941

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel