Senate Bill Proposes to Improve Device Innovation

Two lawmakers have proposed legislation that aims to improve the operational effectiveness at the FDA.

A Bill to Improve Medical Device Innovation (S. 2737) — introduced March 17 by Sens. Amy Klobuchar (D-Minn.) and Pat Roberts (R-Kan.) — would give the FDA the authority to eliminate the premarket submissions requirement for a small set of low-risk, Class I products. It has been referred to the HELP committee.

The bill would update the law to give the agency the authority to no longer require premarket submissions for a small set of low-risk, Class I products, if the FDA deems it appropriate, says JC Scott, senior executive vice president of government affairs at AdvaMed.

In praising the bill, Scott says it would promote transparency in selecting panel members for FDA advisory committees.

It would also give the agency the authority to pilot alternative methods for improving adverse event reporting.

All of the provisions except the adverse event pilot provision were part of the 21st Century Cures Act (IDDM, July 10, 2015).

The “postmarket pilot to improve medical device reporting” provision would allow the FDA to run pilot projects with voluntary participation by manufacturers.

Read the bill here: www.fdanews.com/03-25-16-Bill2737.pdf. — Jonathon Shacat