Product research

What You Need to Know About the FDA’s Total Product Lifecycle Advisory Program Pilot

An FDA initiative to improve medical device development is closer than ever to becoming a reality after surviving negotiations with industry over the reauthorization of Medical Device User Fee (MDUFA) changes.

My last article on MDUFA V addressed the FDA’s Total Product Lifecycle Advisory Program (TAP) pilot featured in the regulatory agency’s commitment letter. Although the pilot could be modified or dropped by the FDA after hearing from the public in April or by lawmakers as they consider reauthorizing MDUFA, the letter offers the latest and most detailed plan for the program.

“The long-term vision of a successful TPLC Advisory Program (TAP) is to help drive faster development as well as faster and widespread patient access to safe, effective and high-quality medical devices from importance to public health,” the FDA said. in the letter. “A mature TAP will also help ensure the enduring success of the breakthrough device program.”

An important feature of the TAP pilot is that it would provide “regular solution-focused engagement” between medical device developers and patients, healthcare providers and payers.

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