Devices

Many FDA Digital Actions Coming

FDA has announced an ambitious series of actions as part of its Digital Health Innovation Action Plan to be completed between now and the first quarter of 2018. Attorney Suzan Onel (Kleinfeld, Kaplan and Becker) writes in an analysis that the agency says it is “redesigning” and “reimagining” its approach to digital health medical devices to develop a pragmatic approach to optimally foster the development of high quality, safe, and effective digital health products while also assuring timely patient access.

To that end, in the next few months it intends to issue:

a new draft guidance with draft interpretations of several of the medical software provisions in the 21^st Century Cures Act, explaining their effect on pre-existing FDA policy on mobile medical applications, medical device data systems, medical image storage devices, medical image communications devices, low risk general wellness products, and laboratory workflow;
a new draft guidance that delineates the clinical decision support software that is no longer under FDA jurisdiction;
a draft guidance on FDA oversight of products with both software functions that fall under agency medical device oversight and software functions that do not;
a final guidance on deciding when to submit a 510(k) for a software change to an existing device subject to 510(k) premarket notification requirements; and
a final guidance adopting internationally converged principles on the clinical evaluation of software as a medical device.

FDA also has indicated it will hire more staff in CDRH with a deep understanding and experience with software development and its application to medical devices, Onel writes. The action plan says the new staff will work with reviewers, compliance officers, and others within FDA to improve the quality, predictability, consistency, timeliness, and efficiency of decision-making.

The analysis outlines the new software precertification pilot program that is part of the initiative and says the agency plans a 1/2018 public workshop to report on and review initial findings from the pilot program.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome