FDA Seeks to Encourage Medical Device Data System Innovation

June 25, 2014—In the Federal Register, the US Food and Drug Administration (FDA) announced the availability of the draft guidance entitled “Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communication Devices.” The agency issued this document to inform manufacturers, distributors, and other entities that the FDA does not intend to enforce compliance with the regulatory controls that apply to medical device data systems (MDDS), medical image storage devices, and medical image communications devices because of the low risk they pose to patients and the importance they play in advancing digital health.

In this document, the FDA is also proposing changes to its guidance entitled “Mobile Medical Applications,” issued on September 25, 2013, to conform to the proposed policy discussed in this draft guidance document. This draft guidance is not final, nor is it in effect at this time, advised the FDA.

Comments on this draft guidance should be submitted to the FDA by August 25, 2014, to ensure they are considered before work begins on the final version of the guidance. Comments—identified with docket number FDA-2014-D-0798—can be submitted either electronically at http://www.regulations.gov or by mail to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, Maryland 20852.

As stated by the FDA in the Federal Register notice, the agency recognizes that the progression to digital health offers the potential for better, more efficient patient care and improved health outcomes. To achieve this goal requires that many medical devices be interoperable with various types of health information technology, including other types of medical devices. The foundation for such intercommunication is hardware and software that transfer, store, convert the format of, and display medical device data. MDDS do not modify data, do not control the functions or parameters of any connected medical device, and are not intended to be used for active patient monitoring, noted the FDA.

In February 2011, the FDA issued a regulation downclassifying MDDS from class III (high-risk) to class I (low-risk). Class I devices are subject to general controls under the Federal Food, Drug, and Cosmetic Act. Since that time, the FDA has gained additional experience with these types of technologies and has determined that these devices pose a low risk to the public.

Therefore, this document proposes a compliance policy whereby the FDA would not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices.

The proposed changes to the FDA’s 2013 Mobile Medical Applications guidance would conform to the policy stated in this document once this document is finalized. Upon finalization, the description of these conforming changes will be removed from this document, and the FDA will issue an updated version of the Mobile Medical Applications guidance that incorporates these changes.

In the FDA Voice blog, Bakul Patel, MS, MBA, commented on the agency’s reasons for the proposed compliance policy that would reduce the regulatory burden on MDDS. Mr. Patel is Senior Policy Advisor in the FDA’s Center for Devices and Radiological Health.

According to Mr. Patel, the proposed guidance for manufacturers of MDDS is consistent with the FDA Safety & Innovation Act Health Information Technology (IT) Report that was issued in April 2014 on the proposed strategy and recommendations for a risk-based framework. Mr. Patel’s commentary on this report is also available online in the FDA Voice blog.

Mr. Patel noted that since the 2011 reclassification of MDDS as class I low-risk products, the Center for Devices and Radiological Health has been working with the Office of the National Coordinator for Health IT (ONC) and the Federal Communications Commission (FCC) on this proposed risk-based regulatory framework for health IT that promotes innovation, protects patient safety, and avoids regulatory duplication. This report placed health IT products in three categories according to their risk to patients, and the FDA’s regulatory oversight of health IT products is focused on the devices that pose higher risk to patients. The proposed framework would put regulatory tools, resources, and expertise where they are most needed; the greater need is with devices that carry greater levels of risk.

From the discussions with ONC and FCC and extensive public feedback, the agency concluded that MDDS products pose little risk. This allows developers of MDDS to focus on making these products better able to operate amongst various devices and technology systems, resulting in stronger products, stated Mr. Patel.