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MDUFA IV (And More) Is Law: Trump Signs A Health-Care Bill

Executive Summary

President Trump's eleventh-hour signature on the FDA Reauthorization Act puts into play about $1bn in device user-fee collections from industry through FY 2022, new US FDA performance goals and a range of device process enhancements and reforms supported by industry.

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Loud And Clear Need In US For OTC Hearing Aids For Mild To Moderate Loss, Congress Tells FDA

Hearing loss is one of the most common conditions affecting older US consumers, with nearly one in three between the ages of 65 and 74 having difficulty hearing, Sens. Warren and Grassley and Resp. Kennedy and Carter note in urging FDA to finalize regulations allowing certain hearing aids to be sold OTC.

US FDA Toying With Idea Of ‘Regulatory Legos’ In MDUFA V

Noting the latest round of user-fee negotiations are coming up, FDA device center head Jeff Shuren recently floated the idea of developing statutory building blocks – or what he calls ‘regulatory Legos’ – that would allow the agency to keep up with rapidly advancing medtech products. Instead of constantly asking Congress for new statutory authorities as technology advances, he said, the FDA could have broader authority to bring new products not covered under its current authority to market.

Medtech Bill Sponsor Sen. Isakson Retiring At Year’s End

Sen. Johnny Isakson, R-GA, who has sponsored and backed several key pieces of device-industry legislation over the last several years, said on 28 August that he will retire from the US Senate on 31 December 2019, due to health challenges.

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