On January 7, 2019, FDA released a position statement from Commissioner Dr Scott Gottlieb, as well as a raft of links to new webpages and documents on software self certification.
This effort has been one of the highlight efforts of the FDA under Dr. Gottlieb. It's worth tracking because FDA often mentions this as a concept it wants to apply in the diagnostics/genomics space as well. (And if fact, some path-breaking approvals for 23andMe a couple years ago (update here) were themselves close to self-certification with open data, as opposed to either the known 510(k) or PMA pathways).
See Gottlieb announcement here; it contains numerous internal links to resources. Coverage at MedCity here; their further analysis here. RAP News here.
I've also cut/pasted below the break.
Separately, for articles on UK NHS investments in digital health and clinical roll-outs, here and here.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new actions under the Pre-Cert Pilot Program to promote a more efficient framework for the review of safe and effective digital health innovations
January 7, 2019