FDA still trying to fine-tune Pre-Cert as pilot enters 2020

The FDA initiative, led by Patel, seeks to reduce certification hurdles for developers of software-based medical devices by shifting responsibility for periodic software updates to manufacturers themselves. But the uncertainty around the Pre-Cert program and the agency's plans for regulating digital health technologies is making some industry observers nervous. Bradley Merrill Thompson, a medical device regulatory attorney at Washington, D.C.-based Epstein Becker Green, says while he appreciates FDA taking its time and "trying to be careful," the progress of the Pre-Cert pilot has been "very slow." In particular, Thompson is concerned the agency hasn't worked out the specific statutory authority required. "FDA can't ask Congress for authority to just do whatever the agency wants to do in its judgment. We need certainty and predictability, and we need to make sure that the agency doesn't go awry," Thompson said. "So FDA needs to get this figured out before they ask for statutory authority to implement it." The pilot, which entered a formal testing phase last year, is focused on software as a medical device (SaMD), which the agency notes ranges from diagnostic software that allows a smartphone to view MRIs, to computer-aided detection software that performs image post-processing to help detect breast cancer.