FDA June 20, 2018
1 Building the Program with Continuous Public Input
As part of the Software Precertification Program development process, FDA has been providing opportunities to the public to provide input on the program elements by publishing incremental versions of the working model of the program. FDA is using this transparent and open approach to provide continuous notice and solicitation of public input, by means of an open public docket, throughout the program development. The public docket is available at https://www.regulations.gov/comment?D=FDA-2017-N-4301-0001.
FDA intends to continue reviewing the public docket approximately every two weeks, and to refine this program by incorporating, as appropriate, comments in future versions of the working model. We encourage the public to provide feedback early and often.
We request comments...
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