Saturday, July 13, 2024

Life Cycle Program Expansion: FDA to Broaden Total Product Life Cycle Initiative

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Life cycle program (TAP) advisory program, designed to accelerate medtech innovation, is planned for expansion by the U.S. Food and Drug Administration (FDA) to include radiological and ophthalmic medical devices starting in October 2024. Furthermore, orthopedic devices will be added to TAP on January 1, 2025. This expansion builds on the agency’s work to test the program with cardiovascular and neurological devices.

The FDA has enrolled 46 breakthrough-designated devices in life cycle program and is meeting its Medical Device User Fee Amendments (MDUFA) goals. The TAP program aims to speed the development of innovative medical devices and technologies critical to public health by providing “early, frequent, and strategic communications” with the FDA, facilitating communication between device developers and third parties.

Life Cycle Program Expansion: FDA’s MDUFA V Commitments Lead to Broader TAP Implementation

The program’s expansion comes as part of the FDA’s MDUFA V commitments. Initially, industry representatives opposed life cycle program, expressing a “fundamentally different view of the MDUFA program and its purposes” during negotiations. Despite this, the industry ultimately agreed to pilot TAP during MDUFA V. The FDA began the pilot in October 2022, expanding it to cover neurological devices a year later.

On October 1, the Office of Radiological Health and the Division of Ophthalmic Devices will join life cycle program, doubling the number of units involved in the program. The Office of Orthopedic Devices will join on January 1, 2025. These additions will help the FDA meet its MDUFA V goals, which include expanding the program to at least four offices in fiscal year 2025, starting on October 1, and enrolling up to 65 additional products in TAP that year.

The FDA has already enrolled 46 breakthrough-designated devices across the first two offices involved in life cycle program. As part of MDUFA V, the agency committed to enrolling up to 60 products by the end of the 2024 fiscal year on September 30. Jeff Shuren, director of the FDA’s Center for Devices and Radiological Health, stated that the agency is meeting all its MDUFA goals.

Life Cycle Program

Life Cycle Program Enhancement: FDA Recruits Experts to Support TAP and Streamline Medical Device Development

Shuren highlighted that the FDA has “recruited numerous subject matter experts to support TAP” and is facilitating interactions between device developers and third parties who can provide input on topics such as technology adoption and reimbursement. This approach is intended to streamline the development process and ensure that innovative medical devices reach the market more efficiently.

The TAP program’s primary objective is to foster the development of medical devices that are crucial to public health. By providing early and frequent communication between the FDA and device developers, life cycle program aims to identify and address potential issues in the development process, thereby reducing delays and accelerating the availability of new medical technologies.

The inclusion of radiological, ophthalmic, and orthopedic devices into life cycle program reflects the FDA’s commitment to broadening the scope of the program and ensuring that a wider range of medical technologies benefit from its support. This expansion is expected to enhance the overall efficiency of the device development process and contribute to the timely delivery of innovative treatments and diagnostics to patients.

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The FDA’s proactive approach in expanding TAP and meeting its MDUFA V commitments underscores the agency’s dedication to advancing public health through innovation in medical technology. By streamlining the regulatory process and fostering collaboration between stakeholders, the life cycle program is poised to play a critical role in the development and deployment of groundbreaking medical devices.

In summary, the FDA’s expansion of the total product life cycle program to include radiological, ophthalmic, and orthopedic devices marks a significant step in accelerating medtech innovation. The program’s focus on early and strategic communication, combined with the recruitment of subject matter experts, aims to streamline the development process and ensure that innovative medical technologies reach the market swiftly and efficiently. This initiative not only meets the FDA’s MDUFA V goals but also holds the promise of improving public health outcomes by facilitating the availability of advanced medical devices.

 

Resource: Food and Drug Administration, July 01, 2024

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