The Promise and Perils of the Pre-Cert Program for Software Developers
​[Posted on: Thursday, August 10, 2017]

Last week we discussed FDA’s revolutionary update to software regulation, namely establishment of a pilot pre-certification program for software developers with demonstrated high quality operations. This week FDA released its first guidance on the pre-cert program, in a question and answer format, further clarifying how the pre-cert pilot will work. The pre-cert program is open to companies located worldwide however with a limit of only 9 developers it is hard to envision how many foreign developers can be accommodated. It seems FDA wants to keep its options to select participants widely open by allowing everyone to apply to be a part of the pilot. As would be obvious, FDA cannot guess at this time how much time commitment will be needed from the developers but it would adapt based on experience interacting with the participants. FDA assures that if it found any compliance issues at the participating company, it would discuss directly with the company before taking any action, presumably giving the company an opportunity to address the issues of non-compliance. Companies who have software products ready for 510k submission are encouraged to not participate, indicating that the pilot program is designed to encourage early developers. This raises the possibility of the one year pilot having few successful products to show off. There are some surprises in the guidance document. In the announcement last week, it seemed that developers who are selected for the pilot pre-certification program will get preferred review of 510k with minimal information. However, the guidance this week denies any such relationship between the pre-cert and the 510k process. It states that companies that want to expedite their 510k applications should pursue the traditional 510k review process rather than trying to leverage their participation in the pre-cert program to speed up their 510k. Also, last week’s announcement said that the pilot program will be reviewed after a year, giving an impression that it was intended for 1 year; however, the guidance denies any defined time-limit on the pilot program. The guidance seems less aggressive and bullish than the initial announcement of the pre-cert pilot. It highlights the realities of implementing programs of this magnitude that change the core regulatory paradigms. It seems that the pre-cert program may be more suitable for developers who have a promising concept but have not done much software development. For developers experienced with the 510k process with advanced software products there seems to less incentive to participate.