FDA Announces “Critical to Quality” Pilot

The FDA is taking applications for its Critical to Quality PMA initiative, which will test a model of early, proactive engagement between PMA applicants and the Agency to identify elements that are key to “product and process quality.” The pilot is aligned with the FDA’s efforts to make the PMA process more efficient and reflects specific device industry feedback that “many of the risks for devices reside in product and process design and post-production activities.”

Over the course of the program, applicants will collaborate with the FDA to define how product design elements elements are controlled in design and manufacturing. Involving the FDA earlier in the marketing process may give devicemakers the opportunity to develop and refine their quality control procedures while assisting the Agency in its manufacturing review. As a result of this effort, participating companies will undergo only a “more focused” post-market inspection, not the standard preapproval inspection, which can be an unwieldy and time-consuming process. Further, the FDA hopes that by implementing and refining quality processes sooner, there may be fewer device failures and recalls. This could ultimately lead to a more efficient marketing process for both applicants and FDA.

This project, which reflects the FDA’s effort to create a more transparent, predictable regulatory pathway, will ramp up quickly. The FDA will accept the first nine applicants who meet the pilot’s criteria into the program, which will run from September 29, 2017, to December 31, 2018.