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Is my Medical Device FDA approved, FDA cleared, or FDA registered? What are the differences? – a Healthmark webinar
May 20 @ 2:00 pm - 3:00 pm
Join Healthmark for this upcoming, informational webinar.
The United States Food and Drug Administration (FDA) is responsible for protecting the public health. The FDA regulates a variety of consumer products, including food, medications, vaccines, medical devices, electronics that emit radiation, cosmetics, veterinary products, and tobacco. The Center for Devices and Radiological Health (CDRH) is a regulatory bureau within FDA and is responsible for implementing and enforcing the laws and regulations which apply to radiation-producing electronic products and medical devices that include lasers and light devices.
FDA Classify the Medical Devices into Class I, II, & III. The class a device falls into is determined by the potential risk of using the device, and medical devices include everything from tongue depressors to pacemakers.
1. Define a Medical Device per Food and Drug Administration (FDA).
2. Describe Federal Code of Registration (CFR), 21 CFR and FDA
3. Discuss how to Determine if Your Product is a Medical Device and the different classes are per the FDA for devices.
4. Discuss FDA review process for the Class I, II, and III medical devices and requirements.
5. Describe Medical Device Reporting (MDR), Safe Medical Devices Act (SMDA), MedSun and the MAUDE database