Medtech Insight is part of the Business Intelligence Division 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


mHealth Regs: FDA Drafts Wellness, Accessories Guidance Docs

This article was originally published in The Gray Sheet

Executive Summary

One proposal addresses regulatory policy for low-risk devices targeting "general wellness" and the other seeks to clarify how FDA intends to regulate products intended as accessories to devices. Mobile health developers have been on the lookout for both.


Related Content

Q&A: What Do FDA’s Recent Medical App Approvals Mean For Industry?
FDA Provides Accessories Guidance, But May Be 'Missed' Opportunity
Wellness Devices May Have More Leeway In FDA Final Guidance





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