The Food and Drug Administration has introduced an innovative TPLC program, which is the Total Product Life Cycle Advisory. The TPLC is expected to provide improved access to medical devices.
Here is why it was a much-awaited move and much-needed move.
A noteworthy feature of the TAP pilot will be its ability to extend regular engagement that would be based on a solutions-oriented approach between patients, payers, healthcare providers, and medical device manufacturers.
New medical devices sometimes never make it from manufacturing to trial for practitioners and patients.
The industry had agreed to pilot the program as part of the MDUFA, elaborated as the Medical Device User Fee Amendment V agreement.
The MDUFA V is now a law. So, the FDA is considering The pilot program. The first launch will be somewhere in January. The first phase of the launch is likely to include around 15 devices in the OHT2, the Office of Health Technology 2:Office of Cardiovascular Devices.
The regulator selected the OHT2 as the former had a rich history of giving breakthrough device designations, staffing, and workload.
“The long-term vision for a successful TPLC Advisory Program (TAP) is to help spur more rapid development as well as more rapid and widespread patient access to safe, effective, high-quality medical devices of public health importance. In addition, a mature TAP will also help ensure the success of the breakthrough devices program,” says the FDA.
Eligibility to Participate in the Pilot Program
Medical product developers can voluntarily participate in the program. The pilot would be open to breakthrough-granted products (fiscal years 2023 to 2025).
Furthermore, fiscal years 2026 through 2027 will also be part of the concept.