News Feature | June 25, 2014

FDA Cuts Its Oversight Of Medical Device Data Systems

By Nick Otto

FSMA Empowers The FDA

The FDA has released new draft guidance on medical device data systems (MDDS) that further extends its original downgrade to a Class 1 device in 2011 and reduces the regulatory burden for MDDS developers. MDDS are systems used to collect, store, convert formats, and display data from other devices, like glucose meters, blood pressure cuffs, and weight scales.

Bakul Patel, the FDA’s senior policy advisor for health IT issues, said in a blog post that the agency would rather MDDS manufacturers focus on innovation and creating stronger, more secure products than worrying about regulatory compliance.

The FDA says the following devices would be exempt from regulatory compliance:

  • MDDS subject to 21 CFR 880.6310,
  • Medical image storage devices subject to 21 CFR 892.2010, and
  • Medical image communications devices subject to 21 CFR 892.2020.

If a device fits into any of the above classifications, the agency says it does not intend to enforce compliance with regulatory controls, including registration and listing, premarket review, postmarket reporting, and quality system regulation for manufacturers.

Patel adds that the Office of the National Coordinator for Health Information Technology and the Federal Communications Commission have provided blueprints for a proposed health IT framework. This fulfills the Food and Drug Administration Safety and Innovation Act of 2012’s requirements that a scheme be developed with an appropriate risk-based framework but that would also allow for innovative and regulatory duplication.

The Friday guidance also made a few changes to the 2013 Mobile Medical Applications Guidance, noting a more relaxed oversight of mobile apps used to display, store, or transmit patient-specific data.

In a blog post on the Hyman, Phelps, & McNamara website, medical device attorney Jennifer D. Newberger wrote that the guidance seems to indicate agency acknowledgement 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.”

She notes that the change in the FDA’s view on a risk-based approach in this situation is “refreshing,” and hopes this can be seen as a precedent for further changes in other forms of data collecting technology such as clinical decision support software.