Important Notice: Our web hosting provider recently started charging us for additional visits, which was unexpected. In response, we're seeking donations. Depending on the situation, we may explore different monetization options for our Community and Expert Contributors. It's crucial to provide more returns for their expertise and offer more Expert Validated Answers or AI Validated Answers. Learn more about our hosting issue here.

What regulations describe the content requirements for IVD premarket submissions?

April 26, 2017content IVD premarket regulations requirements submissions

0

Posted

What regulations describe the content requirements for IVD premarket submissions?

1 Answer

0

Posted

• Investigational Device Exemption (IDE) – 21 CFR 812.20 • Premarket Notification (510(k)) – 21 CFR 807.87 • Premarket Approval (PMA) – 21 CFR 814.20 • Humanitarian Device Exemption (HDE) – 21 CFR 814.104 Currently, there is no regulation describing the contents for a Product Development Protocol (PDP). However, section 515(f)(1) of the Act describes PDP requirements.