Posted 10 December 2015
By Zachary Brennan
At the November meeting on the fourth iteration of the Medical Device User Fee Act (MDUFA IV), the US Food and Drug Administration (FDA) and industry representatives both unveiled new performance targets for de novo submissions, pre-submissions and third-party 510(k) reviews.
The MDUFA IV proposal package, which would take effect in 2017, includes the goals of maintaining the MDUFA III FDA performance targets for 510(k) and premarket approval (PMA) submissions, though performance goals will be expanded for other processes.
For de novo submissions, FDA described the upward trend in the number of such requests, which is forcing the agency to expend greater resources to review them. The added burden means FDA is currently meeting the 120-day target for only about 40% of de novo requests. But the agency proposed for new user fees to increase review capacity such that 70% of de novos can be completed within 120 days by the end of MDUFA IV in 2022.
Industry groups AdvaMed, MDMA and MITA, however, proposed that 90% of direct de novos receive a decision in 120 days, while 90% of post-not-substantially-equivalent (post-NSE) decision de novos receive a decision in 90 days.
On the pre-submission front, FDA also said it’s seeing “a steadily increasing workload,” according to the meeting minutes. And because FDA believes this program has value, it is “concerned that continuation of the program ‘as resources permit’ may negatively affect” it. Therefore, FDA proposed that user fees be provided to increase review capacity such that 95% of pre-submissions can be completed within 60 days by the end of MDUFA IV.
Industry, however, seemed to be more ambitious with its goals, noting the value of consistent, predictable and timely scheduling of pre-submission meetings and feedback.
The industry groups proposed that pre-submissions meetings should be scheduled within 60 days of the request, with a goal of 90%. Pre-meeting feedback, meanwhile, should be sent to the sponsor four business days prior to the meeting for 98% of meetings, industry said.
In addition, they proposed that sponsors with complex submissions should be granted meetings that last longer than one hour and they proposed that FDA update and provide training on the pre-submission guidance.
Third Party 510(k) Review
Due to a “sharp decline” in use of third party 510(k) reviews and increases in review times, FDA said it “believes a course correction is needed,” particularly as a recent survey of FDA staff assessing 510(k)s reviewed by third parties indicated that 80% of such 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.”
FDA’s approach to address these inconsistencies includes “training third parties, providing redacted example reviews, auditing third parties, tracking the scientific quality of the review memos, removing incompetent third parties, and tailoring the program for specific, targeted areas.” FDA also proposed to make a decision on 85% of third party 510(k)s within 30 days by the end of MDUFA IV.
For 510(k)s not reviewed by third parties, FDA said it will increase interactive reviews (IR) earlier in the review process, which could lead to fewer holds and a continued decrease in total time to decision by an average of 10 days.
The agency also said because of the increase in IR, it expects the need for SIMs to be reduced.
Additional Submission Types/Milestones
AdvaMed, MDMA and MITA also proposed to address the time period between a PMA Approvable decision and the issuance of the approval order, and the time from a panel meeting until an FDA decision on a PMA.
The groups proposed to address these issues through a goal of 90% of PMA orders issued within 60 days of an approvable decision. In addition, they proposed that Good Manufacturing Practice (GMP) inspections be conducted 60 days prior to the FDA decision, as well as that for 90% of submissions with a panel meeting the FDA decision be issued within 60 days of the panel meeting.
The American Clinical Laboratory Association (ACLA) also restated its position at the meeting that lab-developed tests (LDTs) are not medical devices under the Federal Food, Drug, and Cosmetic Act.
And if LDTs are regulated as medical devices under MDUFA IV, ACLA proposed that FDA should add a field in the agency’s relevant databases that would enable the data to be reported separately for LDTs, with key metrics comparing in vitro diagnostics to LDTs. ACLA also specifically requested that the commitment letter from the agency state that FDA will treat LDTs no less favorably than other regulated items at CDRH.
Other Odds and Ends
FDA also proposed to decrease the reviewer-to-manager ratio from an average of approximately 11:1 to 8:1 to provide better oversight of the review process and review decisions.
And in response to feedback from AdvaMed, MITA and MDMA on the need for more device-specific guidance documents, FDA said it would “establish a new guidance model for streamlining device-specific guidance documents, increasing the number of such guidance documents, and ensuring they are finalized in a timely manner.”
The next industry-FDA meeting on MDUFA IV is scheduled for 15 December.
FDA – Industry MDUFA IV Reauthorization Meeting November 18, 2015, 9:45 am – 3:45 pm