FDA as Consultant and Confidante? Talking TAP With CDRH’s AJ Baumel

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AJ Baumel, acting associate director of the FDA device center’s TPLC Advisory Program, was interviewed on stage at the MedTech Strategist Innovation Summit in San Francisco last month about what the novel TAP pilot means for industry and for the future of CDRH. “What company, especially a start-up company, wouldn't want an FDA representative available to them as if they were one of their team members down the hallway?” he posed. Here are some key excerpts from Baumel's remarks.

FDA’s TPLC Advisory Program, or TAP, is a small, pilot-stage effort that is less than a year old. But leaders of the agency’s device center say it is the foundation for their future vision of CDRH, where the center is less regulator and adversary and more consultant and confidante to industry. TAP attempts to position FDA to facilitate a company’s broader market-access journey, helping firms address not only regulatory authorization hurdles but also challenges tied to things like reimbursement, commercial strategy, and manufacturing.

This was the message delivered by CDRH’s Alan (AJ) Baumel last month at the MedTech Strategist Innovation Summit in San Francisco, where we interviewed him about the vision and logistics of TAP.

“What we're trying to do is change the landscape and attract more interest in investing in medtech. We believe that the FDA is uniquely positioned to create the relationships between patient groups, provider groups, reimbursement groups and other organizations that can ... help companies,” Baumel, acting associate director for TAP, told the summit audience.


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