Medtech Insight is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

FDA Reiterates Intention To Regulate Only A Small Portion Of Mobile Medical Apps

This article was originally published in The Gray Sheet

Executive Summary

On the last day of hearings by three House Energy and Commerce subcommittees March 19-21, CDRH Office of Device Evaluation Director Christy Foreman largely reiterated FDA’s previously stated approach to regulating mobile medical apps. Meanwhile, Energy and Commerce Committee Vice Chair Marsha Blackburn, R-Tenn., hinted at legislation on the issue

You may also be interested in...



ODE Chief Foreman Departs Device Center; Maisel Will Fill In

Christy Foreman is taking an associate director role in FDA’s Center for Tobacco Products, leaving a vacancy at the top of the Office of Device Evaluation. CDRH Chief Scientist William Maisel will fill in while the device center seeks a replacement.

Bipartisan House Bill Introduced To Curb FDA Health IT Oversight

The SOFTWARE Act, introduced in the House by Rep. Marsha Blackburn, R-Tenn., with support from House members on both sides of the aisle, attempts to redefine regulation of health information technology, and, in particular, limit FDA’s oversight to “products that pose a potential risk to human health.”

Bipartisan House Bill Introduced To Curb FDA Health IT Oversight

The SOFTWARE Act, introduced in the House by Rep. Marsha Blackburn, R-Tenn., with support from House members on both sides of the aisle, attempts to redefine regulation of health information technology, and, in particular, limit FDA’s oversight to “products that pose a potential risk to human health.”

Related Content

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT031909

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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