Sandy Hedberg and Brian Pate of SoftwareCPR highlight a few key points from the meeting. The FDA’s Digital Health Precertification webpage is at the link provided and the slides from their presentation can be downloaded. Basically, the premise is that the FDA will pre-certify a company. Pre-certification will result in a certification level. Based upon the company’s precertification level and the level of risk for the device, the product (or modifications to a product) may be able to go directly to market or undergo a streamlined submission review. The FDA will also require real world data collection.
The FDA did not provide much detail as they intend to develop the details as they go through the pilot. The FDA hopes to enroll around 9 companies in the pilot who are established in software development. It is interesting that the FDA is including a range of device risk and not just focusing on low risk devices. Another interesting aspect is the idea of an SaMD RDK (Regulatory Development Kit) as indicated in one of the FDA slides. This would be an online interactive aide to those developing SaMD in ensuring regulatory compliance and safety. If successful, this new approach may help SaMD manufacturers support more rapid software release and updates, as is common with commercial software products. Precertification (Pre-Cert) Pilot Program: Milestones