On Thursday, Dec. 7th 2017, the FDA issued draft guidance explaining which clinical decision support (CDS) tools won’t be considered devices (and thus will NOT require FDA clearance). This is part of the homework that the FDA needed to do to adhere to the “21st Century Cures” Act.
The draft guidance, “Clinical and Patient Decision Support Software,” clarifies the types of CDS no longer defined as a medical device — and therefore not regulated by the FDA — under the Cures Act.
This draft guidance provides much-needed clarity for electronic health record (EHR) vendors. Intellicure (for example) has CDS rules built into the wound care EHR, which help the practitioner succeed with quality measures relevant to wound care and hyperbaric medicine (e.g. diabetic foot ulcer off-loading, venous leg ulcer compression, arterial screening, etc.). It seems clear from the guidance document that CDS like these are NOT considered devices and do not need FDA clearance.
However, programs that analyze photographs appear to remain medical devices and subject to FDA regulation, based on the definitions below. You should read the entire draft document and see if that’s the way you read it, and submit any comments you have about this issue.
EXCLUDED from FDA oversight as a device:
Section 520(o)(1)(E)(iii) states that, in order to be excluded from the definition of device (and therefore NOT subject to FDA oversight- CF), the CDS function must be intended to enable healthcare professionals to independently review the basis for the recommendations presented by the software so that they do not rely primarily on such recommendations, but rather on their own judgment, to make clinical decisions for individual patients
Based on the above, software that is NOT considered a device under this guidance includes:
- Software that uses rule-based tools that compare patient-specific signs, symptoms, or results with available practice guidelines (institutions-based or academic/clinical society- based) to recommend condition specific diagnostic tests, investigations or therapy.
Still subject to FDA oversight as a device:
Under section 520(o)(1)(E), software functions that are intended to acquire, process, or analyze a medical image, a signal from an in vitro diagnostic device, or a pattern or signal from a signal acquisition system remain devices and therefore continue to be subject to FDA oversight. (This includes feature identification in image analysis.)
An example of a device that FDA intends to focus its regulatory oversight on includes:
- Software that calculates the fractal dimension of a lesion and surrounding skin image and builds a structural map to provide diagnosis
You should submit comments and suggestions regarding this draft document within 60 days of publication in the Federal Register of the notice announcing the availability of the draft guidance (that will be 60 days after December 7th), 2017.
Submit electronic comments to https://www.regulations.gov.