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, the 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 levels of excellence, cleverly named Level 1 and 2, will continue to be a key element of the model. Level 2 is the better of these, which may or may not be obvious. The FDA has never been consistent in rank ordering things noting that a Class III device requires the most pre-market scrutiny while a Class III recall is the least dangerous. An interesting contest would be to name the excellence levels, remembering that even Level 2 extends only to products that have no more than moderate risk. It remains an intriguing question whether companies will want to be known as only Level 1 excellent and whether this information will be publicly available.
Since the FDA will be doing the appraisals, they have also proposed a test methodology with the following questions:
• Does it provide assurance that the organization’s processes and activities are persistent, and does the evaluation work across varying organizational structures.
• Does it determine the clinical responsibility of varying organizational structures, and across varying track records of software products.
• Does it appropriately demonstrate organizational performance against excellence principles to assure safe and effective SaMD.
• Does it identify the metrics or indicators used by the organization to monitor and sustain their processes and organizational effectiveness.
• What are the time and resources needed to complete an appraisal for varying organizational structures.