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

Updated SOFTWARE Act: Still Too Ambiguous For Industry?

This article was originally published in The Gray Sheet

Executive Summary

While some industry experts say the updated version of the SOFTWARE Act strikes a tenable balance between industry's need for certainty and FDA's need to ensure patient safety, others argue it does not go far enough to explicitly state what kinds of health IT software the agency will not regulate.

You may also be interested in...



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.

Active Months Ahead For mHealth Regulatory Policymaking

Multiple guidances, frameworks and legislative activity on mHealth are expected to surface this fall and could have major implications on how the emerging industry is regulated.

Lumicell’s Cancer Imaging Drug Faces Clinical Meaningfulness, Anaphylaxis Risk Questions At FDA Panel

US FDA advisory committee briefing documents say drug-device combo Lumisight (pegulicianine) is effective at picking up cancer but it is not clear whether that translates to patient benefit.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

MT033939

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