The U.S. Food and Drug Administration is an agency of the United States within the Department of Health and Human Services that is responsible for ensuring the safety, efficacy, and security of health-related products through regulatory activities. These activities include reviewing and approving new drugs and medical devices, monitoring the safety and effectiveness of marketed products, conducting inspections and enforcing regulatory compliance, regulating the labeling and advertising of products, and providing information aimed at safeguarding the public by regulating and overseeing the development, manufacturing, distribution, and use of products that impact public health and safety.
The FDA’s Center for Devices and Radiological Health (CDRH), established in 1982 is primarily responsible for medical device regulation. The FDA recognizes that medical devices are an important part of health care service delivery and developments in new technologies can improve diagnoses and treat illnesses. The FDA regulates more than 190,000 distinct devices and the potential risks associated with them; the regulation of medical devices is complex and differs from the regulation of other medical products such as drugs.
At one time, the FDA considered PACS to be a medical device. However, in 2021, the FDA amended a regulation Regulation (21 CFR 892.2050) to change the title of the classification from “Picture Archive and Communications Systems” to “Medical Image Management and Processing System” or MIMPS. In accordance with recent amendments to the Federal Food, Drug, and Cosmetic (FD&C) Act introduced by the 21st Century Cures Act, some of the software functions were excluded from the definition of a medical device. Medical device data systems that transfer, store, convert formats, or display medical device data and results were down-classified from Class III to Class I in 2011. Software functions that are solely intended to transfer, store, convert formats, and display medical device data or medical imaging data are no longer considered medical devices unless the software function is needed to interpret or analyze clinical laboratory tests or other device data, results, and findings. Only hardware that performs medical image storage functions remains within the device definition so that a medical image storage device is a “hardware device that is intended to provide for electronic storage and retrieval functions for medical images.” Under the FDA Code of Federal Regulations § 892.2010 Medical image storage device, a medical image storage device is a hardware device that provides electronic storage and retrieval functions for medical images, and this device type is exempt from the premarket notification procedures.


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