FDA updates Pre-Cert pilot for SaMD
Lessons learned from a digital health software pilot pre-certification program have readied the US Food and Drug Administration (FDA) to test an updated version of the continuous evaluation program for developers of software as a medical device (SaMD).The precertification (Pre-Cert) pilot “will help inform the development of a future regulatory model that will provide more streamlined and efficient regulatory oversight of software-based medical devices,” said FDA in a new Q&A webpage about the pilot program. The Pre-Cert program will be available for “manufacturers who have demonstrated a robust culture of quality and organizational excellence, and who are committed to monitoring real-world performance of their products once they reach the US market,” said the agency.
With the Pre-Cert program, the agency first examines the software or digital health technology developer rather than the device. Companies that pass muster through the Pre-Cert process can seek a streamlined review of SaMD products.
FDA began a test plan in 2019 to assess whether its appraisal of SaMD firms and the accompanying streamlined review process are equivalent to the traditional medical device clearance pathway in terms of achieving “reasonable assurance of safety and effectiveness.”
The update issued on 14 September 2020 outlines the next steps in carrying out the agency’s total product lifecycle approach. This process, said FDA, starts with an organization-level analysis that looks for “commitment to a culture of quality and organizational excellence,” followed by an “excellence appraisal” that looks for demonstrated evidence of these attributes. This appraisal will be based on patient safety, product quality, clinical and cybersecurity responsibility and proactive culture. A two-tier precertification scheme is currently being considered by the agency.
Then, a review determination that defines claims made for the product determines whether a streamlined review is required for reasonable assurance of safety and effectiveness. Potentially, said FDA, precertified firms would be able to market lower-risk devices with either a streamlined review or no premarket review.
SaMD risk categorization will be completed according to the International Medical Device Regulators Forum (IMDRF) risk categorization scheme.
An interactive, streamlined SaMD review process is under consideration by FDA that would include information from the precertification process, as well as additional information about product performance, the clinical association between SaMD output and a clinical condition or conditions, as well as safety measures. The total product lifecycle evaluation process will also include real-world performance data, an area still under investigation and development by FDA.
Nine firms are currently participating in the Pre-Cert pilot, including Apple, Fitbit, Johnson & Johnson, Pear Therapeutics, Phosphorus, Roche, Samsung, Tidepool and Verily. Fitbit announced on 14 September that its electrocardiogram app to assess for atrial fibrillation received FDA 510(k) clearance as well as the European CE mark. It will be available on the Fitbit Sense watch in the US and several other countries in October 2020.
FDA