Pink Sheet 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

Updated SOFTWARE Act: Still Too Ambiguous For Industry?

This article was originally published in The Pink Sheet Daily

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.

A Bad Tip: Boston Scientific Recalls Thousands Of Catheters In Class I Recall

Boston Scientific has recalled more than 6,000 angiographic catheters because the tip can fall off and get stuck in patients, potentially causing serious injury or death. The company says customers should immediately stop using the lots associated with the faulty products and return them.

Topics

UsernamePublicRestriction

Register

PS078563

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