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Device Advice for AI and Machine Learning Algorithms In Medical Imaging

Here is a document of links pointing to FDA guidance documents and other forms of communication. It was compiled by googling CDRH regulatory buzz words. We hope this document is useful. Caveat to all: You won’t know what’s required for your submission until you ask, try, and succeed.

Pre-submission meeting

Here’s some background about the pre-submission process.

IFU: Indications for Use

Part of the definition of your medical device are the indications for use.

It’s never to early to start thinking about, researching, and crafting an IFU for your device.

Comprehensive Regulatory Assistance

510k program

A Premarket Notification 510 is a submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device).

de Novos

  • Special controls accompany all de Novo classifications.
  • Special controls outline submission requirements for medical devices with similar IFU.
  • Special controls are defined for a device type that can be broad or narrow.

If you can’t find a de Novo or existing 510k that is a perfect predicate for your device type: Then find and learn about the closest one or two. It’s a way to start.

PMA

Pursuing a pre-market authorization (PMA)is a regulatory pathway for medical devices that have a higher risk profile than a 510(k). PMAs are not covered here.

Mock Submission

Computer Aided Detection and Diagnosis: CADe, CADx

Examples

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