Will the FDA Pre-Certification Pilot Program Work?

Scott Thiel and Jason Brooke, Regulatory Affairs Professionals Society

Digital health products often fall into a class of their own. With the tsunami of Software as a Medical Device (SaMD) products soon to go through the approval process, FDA is proactively looking to redefine how to get an SaMD product to market, before being inundated. 

Beyond a series of regulatory shifts already enacted, FDA provided updates to the pre-certification pilot program in January aiming to streamline the approval process for qualifying companies, while better leveraging postmarket data collection for SaMD products.

FDA (or potentially an FDA-accredited third party) will assess an applicant’s “culture of quality and excellence.” In other words, the regulatory framework will rely on an evaluation of the thoroughness of the company’s quality practices as it relates to designing, testing, and clinically evaluating its products as well as monitoring real-world performance once the product is on the market. In turn, pre-certified software developers would have, in theory, the option for a reduced review, based upon the trust engendered by being certified.

Currently, nine companies are participating in the pilot program. With initial learnings and results expected near the end of 2019, the rest of the SaMD industry is in a “wait and see” mode — hopeful the program will work, but mindful that many questions remain, including as to its practical viability, whether it provides equal opportunity for companies large and small, and whether FDA even has the legal authority to implement the proposed approach.

Download: Will the FDA Precertification Pilot Program Work?

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