Another Update to the FDA ’s Pre-Certification Model

The FDA has released a January 2019 update to its working model of the precertification program (Pre-Cert) for software that is a medical device (SaMD). As we have previously addressed (here, here, and here) the idea of the Pre-Cert approach is that a reasonable level of safety can be assured by looking at the developer’s quality system for product development rather than by looking primarily at the product itself.  This “look” involves determining a level of excellence for the developer and matching this level to the risk level of the software. Where appropriate, a streamlined review process would then be triggered. The update notes that for 2019, excellence level will be determined directly by the FDA by conducting excellence appraisals of companies (or subunits) participating in the Pre-Cert pilot program. FDA says it will determine what information about the organization, and the organization’s software products, should be part of a company’s application for an appraisal.  Fifteen elements and 5 excellence principles of such an appraisal are given in an Appendix to the update. The FDA says it also intends to collect real-world information on the effectiveness and ease of use of its appraisal methodology. Real world product information is also an important part of determining the effectiveness of Pre-Cert (see below). One might note that real-world information is generally preferred over make-believe information, or at least it used to be. Two l...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Standards & Regulatory Source Type: blogs