Updated SOFTWARE Act: Still Too Ambiguous For Industry?
This article was originally published in The Pink Sheet Daily
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...
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.
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.
The US FDA found more than 2,000 rats at an Arkansas Family Dollar distribution center, leadingto a six-state recall for products including feminine hygiene products, contact lens cleaners and face masks.