WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on introduction of legislation in the U.S. House of Representatives to enable FDA to continue medical device reviews during government shutdowns:

“AdvaMed applauds introduction of the ‘Medical Innovation Never Stops Act,’ and thanks Rep. Tom Emmer (R-Minn.) for sponsoring this important legislation.

“Under current law, FDA is prohibited from accepting new user fees and reviewing new fee-supported medical device submissions for market go-ahead when agency appropriations lapse, which has the potential to clog the innovation pipeline during government shutdowns.

“This legislation would ensure FDA can continiue to accept fees, access those funds and conduct device reviews during any future scenario when agency appropriations lapse. It would also authorize FDA to tap into its pool of pre-paid industry fees – including those tabbed for future reviews or facility registrations – during a lapse of appropriations. At the end of fiscal 2017, FDA’s accumulated pool of unearned fees totaled $7.5 mil., which is not an insignificant sum.

“The provisions in this legislation, if adopted, would help ensure the pipeline of innovative new diagnostics, treatments and cures will not be delayed, ultimately to the benefit of patients. The bill would also help alleviate potentially crippling delays in manufacturer planning and operations, which can be particularly acute for resource-constrainted start-ups and small companies.

“We look forward to working with members of the House and Senate to move forward with this legislation.”

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AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies. For more information, visit www.advamed.org.