The Advanced Medical Technology Association has issued a news release praising final Senate passage of legislation to reauthorize the "Medical Device User Fee Act."
AdvaMed said the law "sets in place measures that should increase the efficiency and predictability of FDA's medical device review process."
According to AdvaMed, the new performance goals in the legislation call for FDA to do the following:
- Reduce total review times and significantly improve review performance relative to current performance;
- Meet with companies if a performance goal on a PMA or 510(k) is missed and work out a plan for completing the review;
- Provide a substantive interaction with applicants halfway through the targeted time for completion of a review; and
- Implement an analysis of FDA's management of the review process by an independent consulting organization, and develop a corrective action plan to address opportunities for improvement.
"This legislation will help improve an already robust review process by giving FDA the additional tools and resources it needs to improve its timeliness and consistency," said Stephen Ubl, AdvaMed president and CEO, in the release. "That means more American patients will have access to safe and effective treatments and diagnostics sooner, which is the shared goal of both FDA and industry."
Related Articles on AdvaMed:
AdvaMed Issues Statement on GAO Implantable Medical Device Procedures Report
AdvaMed Praises House Passage of $30 Billion Medical Device Tax Repeal
AdvaMed Encourages House to Reauthorize Medical Device User Fee Act