Regulatory tips and normal for medical devices
Medical devices, from ideation to post-launch assessment, are regulated by the Food and Drug Administration (FDA) under the Medical Device Regulation Act of 1976 . The FDA’s medical device regulatory pathways — for premarket review, clearance, and approval — are based on three classifications. Medical device makers must adhere to Current Good Manufacturing Practice (CGMP) regulations, which FDA inspectors use to determine if a manufacturer has the facilities, skills, and equipment to produce and pack its product. In addition, the FDA recently decreed that all medical devices must carry a unique device identifier (UDI), readable by both machines and humans, to “improve patient safety, modernize device post market surveillance, and facilitate medical device innovation. These include Essential steps to protecting Global supply chain from UDI disruption, Recommendations for Advancing Safety and Public Health, Cleanliness Validation, Labelling, Medical Device Product Development.The legislation also makes provision for specific types of medical devices, including:single-use devices, active medical devices (energy using), medical devices that contain a pharmaceutical ingredient, systems or procedure packs, custom-made medical devices.
- Obstetrical and medical specialty devices
- cosmetic surgery devices
- Medical specialty devices and ENT devices
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