Devices

Medical Device TAP Accelerator Tips

At the 13^th Annual Symposium on Pediatric Device Innovation, CDRH associate director for the Total Product Life Cycle Advisory Program (TAP), April Marrone, presented tips on the most effective way to use the TAP accelerator, which has already enrolled about 160 innovative devices. An online Medical Design & Outsourcing post says TAP develops resources, offers ecosystem engagement, and collaborates with stakeholders to try to lower and remove barriers to successful commercialization for safe and effective devices. “Once these devices are shown to be safe and effective, they’re breakthrough technologies,” Marrone said. “They have that opportunity to address unmet clinical needs and also healthcare market needs.”

To be eligible for TAP, devices must have FDA Breakthrough Device designation or be accepted into the agency’s Safer Technologies Program.

Marrone said that under MDUFA 6, the agency will use a “Goldilocks zone” with companies that have already obtained first-in-human data but are still a few years away from initiating the pivotal study and are ready to start engaging with the ecosystem and designing the significant body of evidence that is needed.

Companies that enroll in TAP, she said, are assigned a TAP advisor and a lead reviewer. The lead reviewer is there to answer regulatory questions and review the company’s regulatory submission. The TAP advisor works with the company on the nonregulatory components, provides resources, facilitates engagement with the ecosystem, and generally helps troubleshoot, problem-solve, and surmount hurdles companies may encounter.

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AstraZeneca Petition Seeks to Block Cipla's Generic Lynparza

Tidmarsh Sues Aurinia, Alleges Prasad Role in FDA Ouster

ICH M15 Model Evaluation Flexibility, Submission Requirements

FDA Warns of Ventilation Failures in ButterflyBVM Resuscitators