Highlights from FDA’s Draft MDUFA V Commitment Letter

On March 22, FDA announced that it reached agreement with representatives from the medical device industry on proposed recommendations to Congress for the fifth reauthorization of the Medical Device User Fee Amendments (MDUFA V).  MDUFA authorizes FDA to collect fees from certain medical device applicants to fund FDA’s process for review of device applications.  MDUFA V would be applicable to fiscal years 2023 through 2027.

FDA published in the Federal Register a draft version of its MDUFA V commitment letter, which outlines FDA’s updated performance goals in reviewing device applications and planned process improvements.  The most important takeaways from the draft commitment letter are as follows:

Pre-Submissions:  The process and timing for requesting a pre-submission meeting, scheduling the meeting, and receiving feedback from FDA is remaining the same.  However, FDA is significantly increasing (more than double) the number of pre-submission sponsors that will receive feedback within the review goal of 70 calendar days from receipt date or 5 calendar days before the date of the scheduled meeting, whichever is sooner.  Many companies have experienced delays in receiving pre-submission feedback due to FDA’s resource constraints during COVID-19, so this increased goal will be welcome news to companies with devices in development.  As those who have had pre-submission meetings with CDRH understand, preparing for the pre-submission meeting cannot, practically, begin until the written feedback is received.  Having greater certainty as to when written feedback will arrive will allow sponsors consistent time to prepare for the meeting, thereby making the best use of its and FDA’s time.

De Novo Requests:  In the MDUFA IV commitment letter, FDA’s performance goal for review of de novo requests started with review of 50% of requests received in FY 2018 within 150 days of receipt, and increased 10% per fiscal year, ending with 70% within 150 days in FY 2022.  The draft MDUFA V commitment letter starts with a 70% goal in FY 2023, but if the de novo decision goal is met in FY 2023 and the fee revenue amount provided for FY 2026 and 2027 is adequate to support performance improvements, FDA plans to increase the goal to 80% in FY 2026.  Similarly, if the 70% goal is met in FY 2024 and adequate fee revenue is provided, the goal will be adjusted to 90% in FY 2027.

Premarket Approval (PMA) Applications, 510(k) Premarket Notifications, CLIA Waivers by Application, and Biologics License Applications (BLAs):  FDA has not recommended any changes to the timeframe and performance goals for original or supplement PMAs, 510(k) premarket notifications, CLIA waivers by application, or BLAs.

Deficiency Letters:  By January 1, 2023, FDA plans to update the 2017 guidance document on “Developing and Responding to Deficiencies in Accordance with Least Burdensome Provisions” to clarify what constitutes a statement of the basis for the deficiency.  FDA has set performance goals related to providing a statement of the basis for a deficiency in at least 75% of deficiencies in FY 2023, and that goal will increase each fiscal year.

Enhanced Use of Consensus Standards:  Pursuant to MDUFA IV, FDA established a voluntary pilot program called the Accreditation Scheme for Conformity Assessment (ASCA), which grants ASCA accreditation to qualified accreditation bodies to accredit testing laboratories that perform premarket testing for medical device companies.  During the pilot, over 85 testing laboratories have become ASCA accredited (see list here).  The draft MDUFA V commitment letter states that FDA plans to transition the pilot program to a “sustainable and expanded program” by the end of FY 2023, incorporating lessons learned from the pilot program.  While many laboratories have received ASCA accreditation during the pilot, in our experience, FDA does not inquire about the ASCA status of testing laboratories during premarket reviews.  It is possible that with transition to a more established program, FDA will become more interested in whether testing laboratories have ASCA accreditation when reviewing a device premarket application.

Patient Engagement:  The draft commitment letter notes the following plans to increase patient engagement in device premarket reviews: issue a draft guidance to provide best practices on incorporating  clinical outcome assessments (i.e., an assessment that reflects how a person feels, functions, or survives) into premarket studies; support use of innovative technologies to reduce barriers to patient participation in studies; and hold a public meeting by the end of FY 2024 to explore ways to use patient-generated health data to advance remote clinical trial data collection and support clinical outcome assessments.  The feedback received during the planned public meeting on remote data collection could potentially impact FDA’s draft guidance document on “Digital Health Technologies for Remote Data Acquisition in Clinical Investigations.”

Real-World Evidence:  FDA plans to update the 2017 guidance document on “Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices” to provide clarity on acceptable real-world evidence methodologies and best practices.  We are, certainly, supportive of this effort.  It is relatively rare for FDA to be accepting of real-world evidence to support safety and effectiveness.  It would be beneficial for industry to have a better understanding of how real-world evidence can be used in device premarket submissions.

Digital Health:  The draft commitment letter states that FDA will finalize the draft guidance document on “Content of Premarket Submissions for Device Software Functions” by 18 months from the close of the comment period.  FDA will also publish a draft guidance document describing a process to evaluate a predetermined change control plan for digital health devices.

International Harmonization:  FDA plans to “support regulatory convergence” by developing a mechanism for FDA to communicate confidentially with regulatory partners to align international regulatory strategy (e.g., regarding scientific, clinical, or technical information).  By the end of FY 2023, FDA plans to issue for public comment a draft strategic plan with details and timelines on achieving international harmonization objectives.  Starting in FY 2024, FDA will publish an annual assessment of international harmonization activities described in the strategic plan.  Notably, this section of the draft commitment letter did not make any mention of FDA’s proposed rule to harmonize the Quality System Regulation (21 C.F.R. Part 820) with ISO 13485 (see our blog post here), which is one of CDRH’s most significant steps to-date to harmonize its requirements with international regulatory requirements.

Total Product Life Cycle (TPLC) Advisory Program (TAP):  FDA will establish the TAP pilot during the course of MDUFA V.  The goal of this program is to provide for more timely premarket interactions, enhance the experience of all participants in device development and review processes, facilitate improved strategic decision-making by identifying and mitigating product development risks earlier, facilitate regular engagement with FDA review teams, and collaborate to better align expectations regarding generation of evidence and submission quality.  Each fiscal year, FDA will enroll increasing numbers of products in the TAP pilot, starting with 15 in FY 2023, and ending with at least 325 through FY 2027.

A virtual public meeting will be held on April 19th to allow the public to comment on the proposed recommendations in the draft MDUFA V commitment letter (see meeting information and instructions for submitting comments to the docket here).  FDA plans to deliver the final recommendations to Congress by the end of the month.