Minutes from a meeting between representatives from the medical device and diagnostics industry and the Food & Drug Administration reveal a raft of proposed changes to the way the federal watchdog agency reviews the products.
The August meeting, held as part of the seemingly never-ending wrangling between industry and the FDA, involved a baker’s dozen representatives of the agency and 11 people from various industry groups and firms, including Abbott (NYSE:ABT), Boston Scientific (NYSE:BSX), Medtronic (NYSE:MDT), Philips (NYSE:PHG) and LabCorp (NYSE:LH).
“The agency indicated its goal of achieving several objectives that are held in common with industry: Predictability of submission requirements, improved quality of submissions, transparency during the review of submissions, predictability of decision timelines, consistency of review practices, and an adequately resourced premarket program,” according to the minutes of the meeting. “The agency proposal incorporates total time goals in response to Industry’s July 26 proposal. The agency indicated that there are significant concerns about this approach within the agency and within the larger stakeholder community, but expressed FDA’s willingness to work towards an acceptable approach for total time goals because this particular element is important to Industry.”
The FDA’s performance goal proposal include:
- “A defined total time goal for each submission type, with a portion of that time allotted to the agency for review of the submission and a portion allotted to the applicant to respond to feedback from the agency.”
- Milestones for interactions with applicants to “allow the applicant to have a clear understanding of their submission status and the likely timing of a marketing decision.”
- Process improvements, for example “a structured pre-submission process.”
- An annual “Product Development Fee” triggered by “pre-submission” or investigational device exemption applications.
- Pre-Submissions: Goals for scheduling a meeting or teleconference within 60 days of receipt of a complete pre-submission package.
- Initial feedback prior to the meeting and meeting minutes finalized within a set time after the meeting.
- A commitment to certain number of meetings and teleconferences per year.
- Additional meetings honored and “scheduled as quickly as resources permit, and hopefully in the specified timelines” but not subject to the goals.
- The goals would only apply to the first pre-submission meeting request for a specific device. “Subsequent meetings for the same device would not be subject to the goals, although the agency would strive to meet the same timelines.”
- A guidance document regarding pre-submissions, “including criteria for handling situations where the agency’s thinking has changed since the advice given during a pre-submission meeting.”
- Submission Performance Goals: A single high-percentage goal for each performance metric. The proposal included a similar structure for each submission type:
- A planned “Initial Interaction” to “communicate the name of the reviewer and the acceptance of the submission for further review after an assessment against objective acceptance criteria.”
- A “Substantive Interaction” to “communicate with the applicant at the point when the reviewer has completed a substantive review of the submission (this could be a formal deficiency letter, a “telephone hold,” or a status email explaining that no hold is needed).”
- “Interactive Review” immediately following the substantive interaction if no hold is required or following receipt of a response to questions posed in the Substantive Interaction if a hold is required.
- A “Total Time goal” in which a marketing decision would be provided to the applicant. “The Total Time structure would allot a specific number of days to the Agency for an initial internal review and Interactive Review with the applicant, and a specific number of days for industry to respond to questions posed in a Substantive Interaction when a hold was required. … If the Agency does not complete our review within the allotted days, the goal would be considered not to be met for that submission. If the applicant does not respond within their allotted days following a hold, their submission would be considered withdrawn.”
- “The Agency’s proposal includes all 510(k)s for which a fee was paid in goal performance reporting, regardless of the final decision.
- A high percentage metric for each cohort with quarterly reports to “highlight submissions that missed goals, reporting on the total number of elapsed days for each open submission each quarter” until the submission is complete.
- Performance goals for CLIA Waiver applications “with goals designed to be achievable without the application of additional resources in order to remain consistent with the CLIA statute.”
- An increase in time of 25 percent for each of the outlined goals for combination product submissions and companion diagnostic submissions, applied both to agency time and the applicant’s time.
- The performance goals would only apply for annual cohorts with more than 10 submissions of each type.
- Process Improvements : Deploy user fee revenue “to enhance scientific review capacity, reduce the ratio of review staff to supervisors, conduct additional training, and develop targeted retention bonuses to address attrition of review staff.”
- Apply user fee revenue to management training and review staff training, “including a MDUFA III training program and a reviewer certification program, including publishing the curriculum of the certification program and accepting comments from stakeholders.”
- Two “Vendor Days” a year
- Reauthorize the third party review program.
- An independent assessment of review process management to be conducted by a private, independent consulting firm.
- A guidance document outlining objective criteria for revised “refuse to accept/refuse to file” checklists.
- More detailed performance reporting, “increasing the granularity of the data per Industry’s request.”
- Deploy user fee revenue to improve the guidance document process, “including increasing resources dedicated to the process and posting a list of prioritized guidance documents for stakeholder comment.”
- A transition period in order to allow for successful implementation including increasing staffing, training, and putting new systems in place.