EMERGO SUMMARY OF KEY POINTS:

• US legislators and President Trump have finally signed off on FDA user fee reauthorizations that will remain in place through 2022.
• The FDA Reauthorization Act of 2017 (FDARA) keeps current agency funding mechanisms—user fees as well as appropriations from Congress—in place.

After two years of negotiations, the US government has enacted the FDA Reauthorization Act of 2017, or FDARA, that enables the agency to continue using medical device, drug and other health product user fees as a key source of funding through 2022.

Writing on the FDA’s FDA Voice blog, FDA Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren has explained some of the key components of FDARA that will affect US medical device market registrants:

• Flexibility to inspect medical device manufacturing facilities according to risk factors; higher-risk device facilities will warrant more inspection resources from the agency.
• Expanding use of “real-world” data in support of premarket review and other regulatory decisions.
• Increasing funding for development of the National Evaluation System for health Technology, or NEST, which would facilitate more use of real-world evidence in premarket regulatory reviews.
• Improved US market pathways for some medical device accessories as well as for some innovative devices.
• Launching a new device category for over-the-counter hearing aids to boost patient access.
• Improving premarket reviews of combination products, which require coordination between CDRH, the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER).
• Boosting FDA staffing levels, particularly scientific personnel.

Current FDA funding process intact

Throughout the first half of 2017, user fee reauthorization efforts were complicated by Trump administration demands that FDA funding should come solely from medical device and drug registrant user fees, with no resources appropriated from Congress for the agency. Such a scheme would have significantly driven up FDA registration costs for industry. Fortunately, the FDARA signed into law by President Trump retains existing FDA funding mechanisms.

Additional US FDA regulatory resources from Emergo:

• US FDA regulatory consulting service for medical device and IVD companies
• US FDA medical device and IVD regulatory strategy service
• Interactive Calculator: How long it takes to clear a 510(k) application with the FDA
• US FDA medical device regulatory process chart