According to Health Data Management, last Friday, the FDA issued two draft guidance documents that set out how organizations can distinguish low-risk general medical health equipment and applications, and provide a basis for risk assessment of medical device accessories. Suggest. Some people believe that the FDA's move is to strengthen the supervision of Internet medical APP and equipment, as well as accessories.
Details of the draft guide
In one of the draft guidelines, the FDA specifies the criteria for determining low-risk general health care products. The FDA stipulates that general health care products can include:
· Recording equipment;
·Exercise equipment;
·Mobile APP;
·Electronic games;
· other products sold by retailers;
The draft guidance also divides low-risk general health care products into two broad categories:
· Not related to any disease treatment, such as products for weight, sleep and stress management;
· Products that reduce the risk of illness or improve the lives and symptoms of chronically ill patients;
The FDA also describes the conditions and non-applicability applicable to FDA-regulated regulations, such as:
· Promote equipment that can help users improve and maintain a healthy weight, promote a scientific diet and help with weight loss, and will not apply to FDA regulations;
· Promote equipment that can treat or diagnose obesity and eating disorders, and will be under the supervision of FDA regulations;
At the same time, the FDA has defined in a separate draft guide that medical device accessories are devices that are used at least for one parent device or that can be used to support, supplement or add to the performance of one or more parent devices. .
The FDA's draft guidelines suggest that the risk level of the equipment should be assessed when the medical device accessories are used in the parent device, rather than when the parent device is used separately. The FDA also emphasizes that some accessories can be used in parent equipment to reduce the risk of use, so different levels of supervision must be established.
The FDA is currently seeking amendments to the draft guidance as of April 20.
Related person's reaction
The response of the relevant people to this draft guidance is very different. For example, Joel White, executive director of Health IT Now Coalition, said they were very disappointed with the FDA's draft guidance because it sought to define and limit Internet health. He believes that the FDA and the Office of the National Coordinator for Health IT should work together to create a new regulatory framework that will encourage more innovation while protecting user safety.
At the same time, Brad Thompson, a lawyer at Epstein Becker & Green and a legal counsel at mHealth Regulatory Coalition, believes that the draft is far from adequate for medical device accessories. He believes that the FDA should be more To protect the safety of the public, strengthen the regulation and management of medical equipment accessories.
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