The Food and Drug Administration (FDA) issued final guidance on certain medical device regulation policies, as well as draft documents pertaining to how the FDA determines different levels of risk classification for various medical devices.
Specifically, final guidance was issued on medical device data systems (MDDS), while drafts that outline the FDA’s stance on low-risk devices intended to promote general wellness, and its risk classification approach to medical device accessories were also released.Image may be NSFW.
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According to the MDDS guidance, the FDA wants “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.”
The MDDS guidance aligns with the FDA’s intent to not enforce compliance with applicable regulations for technologies that receive, transmit, store, or display data from medical devices, the FDA’s Bakul Patel, M.S., M.B.A. and Jeffrey Shuren, M.D., J.D., wrote in a joint blog post.
“We hope that finalization of this policy will create an impetus for the development of new technologies to better use and display this data,” Patel and Shuren said.
Patel, Associate Director for Digital Health in FDA’s Center for Devices and Radiological Health, and Shuren, Director of FDA’s Center for Devices and Radiological Health, added that by issuing these guidelines, the FDA hopes to continue to clarify which medical devices are low-risk. Those devices will no longer be a focus of the FDA’s regulatory oversight, or the FDA will regulate them under a lower risk classification.
Some of the products that the FDA considers low risk tend to be centered around individuals’ general wellness.
“These products are designed to maintain or encourage a general state of health and may associate a healthy lifestyle with reducing the risk or impact of certain diseases or conditions,” Patel and Shuren wrote. “We hope this policy fosters the development of low-risk products intended to promote a healthy lifestyle.”
The duo also discussed the FDA’s draft guidance for medical device accessories and the potential security risk factors that could come with them. Regulation for medical device accessories will depend on the presented risks when the items are “used as intended with their parent devices and on the level of regulatory controls necessary to assure their safety and effectiveness, independent of the risks of their parent devices.”
“Some accessories can have a lower risk profile than that of their parent device and, therefore, may warrant being regulated in a lower class,” Patel and Shuren said. “Through such smart regulation we can better facilitate innovation and at the same time protect patients.”
Along with medical device guidance, the FDA has also been focusing on improved medical device cybersecurity. Toward the end of last year, the agency released its “Management of Cybersecurity in Medical Devices” guidance to update manufacturers on medical device cybersecurity best practices.
The guidance was meant to supplement the FDA’s previously released information and be viewed as recommendations, not regulatory mandates. Essentially, the FDA said that manufacturers need to “develop a set of cybersecurity controls to assure medical device cybersecurity and maintain medical device functionality and safety.”
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