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GUIDANCE DOCUMENT

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices Guidance for Industry and Food and Drug Administration Staff February 2015

Final

Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices

Docket Number:
FDA-2014-D-0798
Issued by:
Guidance Issuing Office
Center for Devices and Radiological Health

The 21st Century Cures Act (12/13/2016) amended the definition of “device” in the Food, Drug and Cosmetic Act to exclude certain software functions, including some described in this guidance document. FDA is assessing how to revise this guidance to represent our current thinking on this topic. For additional information, contact digitalhealth@fda.hhs.gov or refer to https://www.fda.gov/MedicalDevices/DigitalHealth/default.htm.


FDA 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 other types of medical devices and with various types of health information technology. The foundation for such inter-communication is hardware and software that transfer, store, convert formats, and display medical device data or medical imaging data.

The FDA is issuing this guidance document to inform manufacturers, distributors, and other entities that the Agency does not intend to enforce compliance with the regulatory controls that apply to MDDS, medical image storage devices, and medical image communications devices, due to the low risk they pose to patients and the importance they play in advancing digital health. On February 15, 2011, the FDA issued a regulation down-classifying MDDS from Class III (high-risk) to Class I (low-risk) (“MDDS regulation”).

Class I devices are subject to general controls under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Since down-classifying MDDS, 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, the FDA does not intend to enforce compliance with the regulatory controls that apply to MDDS devices, medical image storage devices, and medical image communications devices.


Submit Comments

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2014-D-0798.