Apr 5, 2022

EMERGO BY UL SUMMARY OF KEY POINTS:

  • US FDA issued updates to its Third Party Review program goals.
  • FDA has set new digital health goals to streamline medical device reviews.
  • The agency will launch a pilot Total Product Life Cycle program to help spur more rapid medical device development.

The US Food and Drug Administration (FDA) has issued a commitment letter describing draft amendments to its medical device review procedures. The agency is currently finalizing the process improvements detailed in FDA Medical Device User Fee Amendment V (MDUFA V). Once adopted, MDUFA V will set performance goals and procedures for medical device submissions for the fiscal years 2023 through 2027. (Additional MDUFA V coverage from Emergo is available here.)

How will the FDA review it if I work with a third party on my submission?

The FDA will continue to support its Third Party Review program to eliminate unnecessary re-reviews of third-party assessments. By making training and other resources available, the agency will help streamline the process of accepting third-party reviews.

The FDA will facilitate third party reviewers by:

  1. Provide training for third parties seeking accreditation by the FDA, including redacted review memos and other instruction tools.
  2. Update third parties and industry members when agency expectations for a certain device change.
  3. Audit and provide retraining tailored to accredited third parties, based upon audit results.
  4. Publish performance on the FDA website of accredited third parties that have at least five completed submissions, including average number of holds, average time to a Substantial Equivalence (SE), and rate of Not Substantially Equivalent (NSE).

The FDA will consider the factors described in its “510(k) Third Party Review Program” guidance to determine device eligibility for the program.

What will the FDA’s digital health goals be?

The agency will continue to build upon its digital health expertise and its work to align FDA review processes with software lifecycles for digital health products.

To streamline FDA reviews, the agency will:

  1. Continue to develop digital health technology and software expertise to facilitate premarket submissions that include software or interoperable devices, or otherwise incorporate digital health technologies, such as artificial intelligence (AI), machine learning (ML), Virtual Reality (VR), Mixed Reality (MR), Augmented Reality (AR) or wearables.
  2. Expand staff understanding of digital health topics through training and infrastructure, such as the Focal Point Program, to enhance evaluation consistency.
  3. Continue to participate in international harmonization efforts related to digital health, including work on developing software and other digital health convergence tasks.
  4. Finalize draft guidance within 18 months from the close of the comment period for “Content of Premarket Submissions for Device Software Functions.”
  5. Publish draft guidance describing the process to evaluate a predetermined change control plan for digital health devices.

What are the FDA’s goals for its new Total Product Life Cycle program?

The FDA is establishing a pilot of the Total Product Life Cycle (TPLC) Advisory Program under MDUFA V. The long-term vision for the TPLC Advisory Program, or TAP, is to spur more rapid medical device developments and patient access to safe, effective, high-quality medical devices.

The TAP Pilot is intended to demonstrate the benefits of the process improvements to the agency’s early interactions with participants and stakeholders.

Through TAP, the FDA will provide strategic engagement for innovative devices by:

  • Improving the participant experience by providing more timely premarket responses.
  • Enhancing the participant experience throughout design and development.
  • Facilitating improved strategic decision-making during product development, including earlier identification, assessment, and mitigation of product development risks.
  • Coordinating solutions-focused collaborations between the FDA and all stakeholders involved in early device development.
  • Collaborating to better align expectations regarding evidence generation and improving submissions quality and premarket review process efficiency.

The FDA has set several goals for TAP to achieve the objectives listed above.

The agency has set these goals for TAP:

  • FY 2023: enroll up to 15 products in a soft launch in one Office of Health Technology (OHT).
  • FY 2024: continue to support products enrolled in the previous fiscal year and expand to enroll up to 45 additional products in at least two OHTs.
  • FY 2025: continue to support products enrolled in previous fiscal years and expand to enroll 65 additional products in at least four OHTs.
  • FY 2026 – FY 2027: in addition to the above, the selection of the OHTs will consideration of experience from prior years and input from industry and other stakeholders.

The agency has set these enrollment parameters for TAP:

  1. Participation in the pilot is voluntary.
  2. For FY 2023 – FY 2025, products will be those with a granted Breakthrough designation.

For FY 2026 – FY 2027, products will be those with a granted Breakthrough designation for inclusion in the Safer Technologies Program (STeP).

  1. Participants have not submitted a Pre-Submission about the product after granted Breakthrough designation or requesting inclusion in STeP.
  2. Products will be early in their product development process (e.g., have not yet initiated a pivotal study at the time of pilot enrollment.
  3. Each participant may enroll a maximum of one product in the pilot per fiscal year.
  4. Participants will be enrolled on a first-come, first-served basis.

The TAP Pilot will be assessed using an independent third party or parties. The assessment will include a participant survey and quantitative and qualitative success metrics, starting in FY 2024.

Learn more about US FDA medical device regulations and compliance from Emergo by UL:

  • FDA 510(k) consulting for medical device and IVD companies
  • FDA QSR (21 CFR Part 820) quality management system consulting

Author

  • Kathryn Burke's picture
    Kathryn Burke

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