US FDA Relaxes Regulatory Requirements for Medical Device Data Systems

Medical device data systems (MDDS) used to support digital health technologies will no longer be required to comply with the US Food and Drug Administration’s regulatory controls, according to new guidance from the agency.

The FDA’s draft guidance states that the low risk posed to patients and users by MDDS, medical image storage devices and medical image communications equipment justifies relaxing regulatory requirements for these systems. MDDS and related technologies had previously been down-classified from Class III to Class I in 2011.

Which MDDS devices would qualify?

Specific MDDS devices and technologies covered by the draft guidance include:

  • MDDS falling under 21 CFR 880.6310
  • Medical image storage devices under 21 CFT 892.2010
  • Medical image communications devices under 21 CFR 892.2020

US regulators do not intend to enforce compliance for devices subject to the three regulations listed above in terms of registration and listing, premarket review, post-market reporting and FDA Good Manufacturing Practice quality system requirements.

Effects on the FDA’s mobile medical app regulatory approach

The new FDA draft guidance also changes the agency’s approach to regulating mobile medical apps and technologies—at least where MDDS is concerned. Sections V-A-1 and V-B as well as Appendices B, C and D of the FDA’s Mobile Medical Applications guidance have been amended to exclude MDDS, medical image storage and medical image communication devices from the scope of the agency’s regulatory remit.

Signaling that it won’t enforce compliance requirements for peripheral devices such as MDDS suggests the FDA may be proving more receptive to industry demands for a more nuanced and targeted approach to mobile health technology regulation than was initially feared.

Stewart Eisenhart

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