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

Bipartisan House Bill Introduced To Curb FDA Health IT Oversight

This article was originally published in The Gray Sheet

Executive Summary

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.”

You may also be interested in...



'Cures' Bill Circumvents FDA On Medical Software Regs

Lobbyists for the medical software industry, and particularly clinical decision support tools are "delighted" that lawmakers are getting around the agency by explicitly stating the types of software it is not allowed to regulate in the 21st Century Cures Act, set to pass Congress by the end of the year.

Industry: New SOFTWARE Act Provides Certainty

Rep. Blackburn’s SOFTWARE Act has changed substantially since it was first introduced and is being praised by device manufacturers for providing much needed clarity on how far FDA can go to regulate Medical and Health software.

Industry: New SOFTWARE Act Provides Certainty

Rep. Blackburn’s SOFTWARE Act has changed substantially since it was first introduced and is being praised by device manufacturers for providing much needed clarity on how far FDA can go to regulate Medical and Health software.

Related Content

Topics

UsernamePublicRestriction

Register

MT032544

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