Pre-Cert Pilot: FDA Updates on Framework, Asks for Input
The US Food and Drug Administration (FDA) provided new information about its software pre-certification pilot Tuesday with the release of an updated version of its working model.FDA is also calling for input from the public, which it says it will review on a biweekly basis as it works to fine tune the program before a 1.0 version of the program is launched next year.
The program, first announced by FDA one year ago, aims to shake up the agency's traditional product-based approach to reviews for digital health products by creating a path for developers to be pre-certified based on their software development, validation and maintenance practices.
Currently, FDA says it plans to only allow developers of software as a medical device (SaMD) to participate, though the agency says it plans to use the insights gained from the 1.0 version of the program in 2019 to expand eligibility to developers of software in a medical device (SiMD) and other software that is considered an accessory to hardware-based devices.
In September, FDA selected the first nine companies to participate in the pilot for the program, including Apple, Verily, Johnson & Johnson and Samsung.
In April, FDA released a 17-page document detailing version 0.1 of its working model for the program.
Now, in the agency's 45-page document Developing Software Precertification Program: A Working Model Version 0.2, the agency is expanding on the program and responding to comments received on the program so far.
In the version 0.2 document, FDA tags sections that it is looking for public input on with an "I," and sections that were developed in response to public docket comments with a "C".
According to the version 0.2 release notes, the updated document further clarifies the program's scope and adds details about the excellence appraisal component of the program, review pathway determinations, streamlined premarket review processes and real-world performance.
FDA also says the update provides additional details on how it might leverage the International Medical Device Regulators Forum (IMDRF) risk categorization framework "to enable precertified companies to determine the premarket review pathway for their products."
FDA, Developing Software Precertification Program: A Working Model Version 0.2