10 Changes to the FDA ’ s Pre-Cert Program Model

In June 2018 the FDA released an update to its working model of the Software Pre-Cert Program that addresses 10 areas of comments received as a result of the earlier call for public input. In an usual step, these comment driven changes are clearly identified in the document, rather than leaving it to reader to figure out what is new or different. I will briefly address each of these ten areas. 1. The FDA has reiterated that Pre-Cert can apply to organizations of any size. This isn’t new. 2. The FDA notes that it agrees with the principle that there should be flexibility in the “excellence” appraisals that will be applied to organization seeking certification. However, we might also note that flexibility inherently means inconsistency such that comparisons of two or more versions of being excellent may be difficult. 3.The FDA clarified that the Pre-Cert program only applies to software that is a medical device. This is hardly surprising since things that aren’t medical devices are not within the relevant component of FDA’s purview. If a software product is not a medical device some other agency may or not have jurisdiction (eg FTC). None-the-less, the FDA is currently studying non-medical device software as directed by the 21st Century Cures Act. 4. The FDA has said that it indeed will apply least burdensome considerations in establishing excellence models. This is also not surprising since least burdensome is part of FDA’s mandate and the agency routinely descri...
Source: Medical Connectivity Consulting - Category: Information Technology Authors: Tags: Standards & Regulatory Strategy & Planning Source Type: blogs