July 2019 SaMD PreCert Update

We have been following the FDA's Software as Medical Device (SaMD) Pre-Cert pilot. The premise of the pilot is that a quality software development process, which has been certified by the FDA, can provide a reasonable assurance of safety and efficacy for low and medium risks SaMD without it being necessary to examine the product itself as in the more traditional pathway. There is supposed to be value in doing this quality approach, i.e., it's not just different but better. In the latest update FDA has highlighted some progress and ongoing activity. In one exercise the FDA has retrospectively applied its excellence appraisal methodology to previously cleared products. It was determined that a regulatory decision could be made using the information acquired from the mock appraisal. In addition opportunities were identified to simplify the Excellence Appraisal and Streamlined Reviewprocess for sponsors and reviewers. The FDA also continues to work with pilot participants and other interested stakeholders who have volunteered for the 2019 testing to conduct an Excellence Appraisal and, in some cases, to test Pre-Cert program components through the review of a De Novo request or 510(k) submission (the FDA will also conduct traditional review for all test cases). The Pre-Cert team was available for questions/collaboration with participating companies as they prepared for their Excellence Appraisal. This availability helped companies (and the FDA) align expectations and share...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Standards & Regulatory Source Type: blogs