CDRH Pre-Cert Program Design to Shift Regulatory Paradigm

The time for revamping the regulatory approach on medical technologies has come, said CDRH Director Jeff Shuren during a recent FDA workshop on developing the digital health software Pre-Cert program, adding current policies are outdated.

The shared vision for the Pre-Cert program includes getting the right digital health products to the right patients at the right time while providing reassurance of safety and effectiveness. Those that gain pre-certification could potentially bypass certain FDA requirements, such as submitting a product for premarket review, to reach the market at a faster pace.

The Pre-Cert workshop was designed for “setting the stage,” said Bakul Patel, CDRH’s associate director for digital health, stressing that a successful paradigm shift focusing on software is heavily dependent on collaborative interactions. Future workshops will consider product-level risk categorization frameworks, as well as post-market surveillance and real-world evidence.