What are the different types of FDA regulations for medical devices?
Date:2023-01-09
1. Premarket approval (PMA): PMA is the most stringent type of device marketing approval. Before a device can be marketed, it must go through a lengthy and expensive process to prove its safety and effectiveness, as determined by the FDA.
2. Premarket notification (510(k)): A 510(k) is a premarket notification required when a medical device has significant changes or modifications compared to a similar device that is already on the market, but still meets safety and effectiveness criteria.
3. Humanitarian Device Exemption (HDE): This type of FDA approval requires a device to be safe and effective for use in a particular indication or disease. The device must also have no existing approved alternative treatment and meet certain additional criteria before it can be approved.
4. Investigational Device Exemption (IDE): An IDE can be granted to a medical device company to allow them to test a device on humans for research purposes. The device must be considered safe and perform its intended function before it is approved for research.
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