Software Pre-certification May Mean More Surveillance: Attorney

Attorney Vernessa Pollard (McDermott Will & Emery) says that companies that secure digital health software precertification from FDA “may have increased post-market surveillance and data collection obligations, with a particular emphasis on real-world data.” Writing in an Of Digital Interest online blog post, she says that increased post-market reporting obligations for SaMD (software as a medical device) in the precertification program may allow FDA to encourage innovation and faster premarket review cycles while still conducting a thorough assessment of a product’s safety and efficacy when used by a broader patient population.

“Companies and investors should make sure their medical device and SaMD development strategies take into account the evolving FDA regulatory regimes for digital health and the possibility of greater post-market study and surveillance obligations,” she concludes.