FDA to stop regulating some medical device software

Bakul Patel

FDA will exercise "enforcement discretion" in its regulation (or lack thereof) of medical device data systems by opting not to enforce the general controls, such as product registration and Quality System Regulation, that normally apply to Class I devices, the agency said in a June 20 draft guidance.

Medical device data systems are "are off-the-shelf or custom hardware or software products that transfer, store, convert format, and display medical device data without modifying it, and without controlling or altering the functions or parameters of any connected medical devices," explains FDA senior policy advisor Bakul Patel in a blog post.

The move means the FDA is leaving the devices unregulated, although the agency still claims the right to regulate them if it desires. In 2011, the FDA downgraded medical device data systems from Class III and Class I, and the new draft guidance brings the process of deregulation to its logical conclusion.

Examples of such devices include software (such as that written by a hospital or third party on a one-off basis) that transfers data from a medical device such as a ventilator into a centralized repository, software that converts data from one format to another, and medical image storage and communications devices, according to the draft guidance.

The draft guidance proposes changes to the 2013 mobile medical app guidance in order to make it consistent with the new recommendations about medical device data systems. The changes to app guidance would also clarify that the "apps subject to FDA's enforcement discretion include those that assess the risk of cardiovascular diseases or are intended to be used in diabetes management," says the FDA Law Blog.

"By eliminating the regulatory obligations of these low-risk products, FDA seems to be acknowledging that it cannot reasonably regulate all, or even a majority, of marketed software products, and its resources must be dedicated to those that present a potentially higher risk to patients," writes the law blog's Jennifer Newberger.

Patel said the reform to medical device data systems regulation was made in consultation with The Office of the National Coordinator for Health IT and the Federal Communications Commission as part of the three agencies' efforts to craft a broader framework for the regulation of health IT.

- read the draft guidance
- read Bakul Patel's blog post
- read the FDA Law Blog's take