Streamlined Development is Goal of FDA’s Total Product Life Cycle Program
CDRH’s new development initiative — Total Product Life Cycle Advisory Program (TAP) — taps into an FDA goal: to ensure U.S. patients are first to benefit from innovative medical devices that, while developed quickly, are of high quality, safe and proven effective, and that include input from patients, providers and payers early in the process.
“TAP is … intended to de-risk the medical device valley of death,” saidCDRH DirectorJeff Shuren, referring to the metaphorical scary place where promising innovative technologies fizzle out, often because of the inability of product developers to meet — or even understand — the expectations of FDA regulators.
TAP is a two-way street, designed to help regulators understand the development needs of devicemakers and vice versa. By facilitating clear communication among regulators, product developers and key stakeholders, the FDA expects to improve its ability to troubleshoot issues that have been stumbling blocks to authorization in the past.
A key goal, according to Shuren, “is to increase the predictability and reduce the time from concept to commercialization, in part, by facilitating robust engagement early in the process with the FDA, industry and key stakeholders.”