CDS Coalition Seeks Industry Input on the Elements of FDA’s Proposed Software Precertification Program

The CDS Coalition is distributing a survey designed to get input from the medical software industry on the FDA’s new vendor precertification program.  FDA’s planned program will replace at least some product-specific premarket review for class II software medical devices, with precertification of software vendors to assess whether they meet quality guidelines the agency is still developing.

The survey assesses the extent to which software companies are willing to subject themselves to these additional quality screens, in exchange for the easier path to market. We are gathering this information to present the results at a public workshop FDA plans to hold in January 2018. We will continue to collect survey responses until January 12, 2018, giving us time then to analyze the results before the public workshop.

The survey targets vendors that develop, or plan to develop in the future, standalone software (meaning software that does not drive a hardware medical device) that FDA regulates in class II. The reason is simple: FDA’s objective is to lessen the premarket regulatory requirements for class II devices.  Most class I medical devices do not undergo premarket review.

We are not asking participants to register because we want to afford them anonymity. While it’s probably impossible for survey participants to coordinate with all of their colleagues, we are interested in receiving only one response per company.

If your company is interested in participating, please click here to take the survey by January 12, 2018.