Jun 26, 2014
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The FDA’s draft guidance states that the low risk posed to patients and users by MDDS, medical image storage devices and medical image communications equipment justifies relaxing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Specific MDDS devices and technologies covered by the draft guidance include:
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The new FDA draft guidance also changes the agency’s approach to regulating mobile medical apps and technologies—at least where MDDS is concerned.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.
Final rules to expedite medical device data systems’ (MDDS) path to market in the US have been issued<
Testifying before a US House of Representative hearing on mobile medical technology on March 21st, FDA official Christy Foreman indicated that the agency’s approach to mobile medical app oversight will not include smartphones or tablets used to access such devices.
Highly anticipated draft guidance on mobile medical applications has been published by the FDA’s Center for Devices and Radiological Health (CDRH) and Center for Biologics Evaluation and Research (CBER).
Targeting specific subsets of mobile medical device applications, the guidance should help answer some longstanding industry questions of how—or whether—US and other regulators would approach such devices. The guidance could furthermore serve as a template for other medical device market regulators determining how to establish requirements for this burgeoning sector of the device industry.