FDA, Industry Make Progress on MDUFA IV Negotiations

Negotiations continue to move forward for the fourth installment of the Medical Device User Fee Act, with FDA and industry representatives focusing attention on improving performance of the review process.

The FDA is proposing to introduce new user fees to increase review capacity for de novo requests and pre-submissions, according to Nov. 18 meeting minutes released earlier this month.

The FDA says there has been an upward trend in the number of de novo requests, thus increasing the agency’s workload. That additional work — coupled with limited resources — means the FDA is meeting the 120-day target for about 40 percent of de novo requests.

“FDA proposed that user fees be provided to increase review capacity such that 70 percent of de novos can be completed within 120 days by the end of MDUFA IV,” the meeting minutes say.

The Medical Device Manufacturers Association, Medical Imaging Technology Alliance and AdvaMed want more and are pushing for 90 percent of direct de novos to receive a decision in 120 days, while 90 percent of post-not-substantially-equivalent decision de novos would receive a decision in 90 days.

Meanwhile, the third-party 510(k) program has experienced increasing review times and a sharp decline in use. The FDA believes that “a course correction is needed,” following a recent survey of agency staff who assessed 510(k)s reviewed by third parties. According to survey results, 80 percent of submissions had major issues in five key areas, including not providing a substantial equivalence rationale, not providing a summary of the review and not providing a comparison to the predicate device.

As a result, the FDA has proposed a multipronged approach by training and auditing third parties, providing redacted example reviews, tracking the scientific quality of the review memos, removing incompetent third parties and tailoring the program for specific, targeted areas.

“With dedicated resources to correct and maintain oversight of the program, FDA proposed to make a decision on 85 percent of third party 510(k)s within 30 days by the end of MDUFA IV,” say the meeting minutes.

During the previous MDUFA IV meeting, which took place Oct. 26, stakeholders and FDA officials nominated priorities for reauthorization of the program, including incorporating patient perspectives in FDA reviews, using data from device and patient registries more efficiently for pre- and postmarket purposes and coordinating the FDA’s work in areas such as combination products and companion diagnostics to ensure adequate user fee funding (IDDM, Nov. 13).

Read the Nov. 18 meeting minutes here: www.fdanews.com/12-15-MDUFA-Minutes.pdf. — Jonathon Shacat