FDA launches TAP Pilot and Proposes Breakthrough Status for Devices Addressing Health Disparities
The FDA has launched the TAP Pilot Program (Total Product Life Cycle Advisory Program) for manufacturers to engage with the FDA at earlier stages within the medical device design and development process. The purpose of the pilot program is for the FDA to provide input into product development and decrease the amount of time devices are brought to market. The FDA has stated that some of the goals of the program include identification of device risks at an earlier stage in the development process, increasing submission quality, and enhancing the efficiency of the premarket review process.
FDA will start accepting products into its total product lifecycle advisory program (TAP) pilot starting in January. The agency will only accept 15 cardiovascular breakthrough devices into the pilot program in the first year. FDA published a notice on how it plans to proceed with the TAP pilot, which will be open to a limited number of sponsors starting on 1 January 2023. “Consistent with the MDUFA V commitment letter, FDA initially intends to include only devices with a granted Breakthrough designation in the TAP Pilot in FY 2023 – FY 2025 and intends to include devices with a granted Breakthrough designation or request for inclusion in the Safer Technologies Program (STeP) in FY 2026 – FY 2027,” FDA said. FDA intends to accept only 15 cardiovascular devices in the first year of the pilot program through its Office of Health Technology 2 (OHT2): Office of Cardiovascular Devices because historically it tends to get the largest number of breakthrough device designations, workload, staffing levels and expertise. The agency notes that as of 30 June OHT2 has granted 163 Breakthrough designations which accounts for almost a quarter of the 687 Breakthrough designations granted by CDRH since the program started.
FDA) Center for Devices and Radiological Health (CDRH) has proposed that devices that aim to eliminate disparities in health care be designated breakthrough products. It states that “when assessing eligibility for the Breakthrough Devices Program using the statutory designation criteria, FDA intends to consider technologies and device features that may help to address health and/or health care disparities and promote health equity by providing for more effective treatment or diagnosis in populations that exhibit health and health care disparities.” FDA also proposed that non-addictive medical products for treating pain or addiction be considered eligible for breakthrough designation. Lastly, a new confidentiality clause has been proposed stating the agency will not disclose breakthrough therapy requests and decisions made on these requests.
The FDA has confirmed medical device user fees for fiscal year 2023 which consists of major increases from 2022 for various submission types. Most notably, 510(k) premarket submissions saw a fee increase of 56% (from $12,745 to $19,780). Premarket approvals and De Novo classifications both saw an increase of 18%. The new user fees will take effect starting October 1, 2022 which is the start of the FDA’s fiscal year.
FDA announced that you may now send electronic submissions online through the CDRH Customer Collaboration Portal (or CDRH Portal). This reflects a move to use of a central site to submit your 510(k) and de novo submissions and track their progress. According to FDA, anyone can now register for a CDRH Portal account to send a premarket submission online.
FDA released two final guidances to assist manufacturers of moderate- to high-risk medical devices to comply with the agency’s postmarket surveillance requirements and to better understand the agency’s expectations for conducting post-approval studies of these products. The procedures guidance provides recommendations on the format and content of PAS submissions as a condition of premarket approval (PMA) and is intended to help facilitate reviews of these PAS protocols. The postmarket surveillance guidance addresses FDA’s interpretation of postmarket surveillance orders under section 522 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) with respect to certain Class II or Class III medical devices. The revisions clarify the information that should be included in postmarket surveillance plans, as well as enrollment reports, interim reports and final reports, said FDA. The final version also clarifies how changes to an approved post market surveillance plan should be made.
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has officially delayed implementation of planned medical device regulations by 12 months in order to avoid potential supply disruptions and allow more time for preparing necessary systems and processes. A new MHRA announcement states that the UK Medical Device Regulations 2002 (UK MDR 2002) currently sets a June 30, 2023 deadline for accepting medical devices with CE Marking, after which time transition plans whereby manufacturers will need to obtain UK Conformity Assessment (UKCA) certification as part of their UK compliance activities take effect. The new announcement extends the deadline to July 2024 for launching the transition from CE Mark to UKCA certification of medical devices in Great Britain.
The Simbex Regulatory and Reimbursement Recap is a monthly briefing for news in the regulatory and healthcare reimbursement space relevant to Simbex areas of expertise. The briefing is curated by Amaris Ajamil, PhD, RAC, Simbex Senior Quality Assurance/Regulatory Engineer, Amit Guruprasad, Simbex Quality Engineer, and Angela Smalley, PhD, Simbex Senior Commercialization Consultant. A story’s inclusion does not imply endorsement by Simbex.