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.
- Slides: Pre-Submissions and Meetings with FDA Staff
- Guidance document: Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and Drug Administration Staff
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.
- Google “fda cdrh pma” .
Sarah please download and then upload the MOCK SUBMISSION documents here
Mock Submission
- Webpage: MDICx webinar that includes a presentation on mock submissions to FDA/CDRH.
- Webpage: All the mock submission documents to and from the MDIC team and FDA.
Computer Aided Detection and Diagnosis: CADe, CADx
- Computer added detection (CADe) guidance – Radiology
Examples
- Device type: Radiological computer-assisted diagnostic (CADx) software for lesions suspicious for cancer.
- QuantX (DEN170022: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170022.pdf).
- Classification Product Code: POK
- Device type: Radiological Computer Assisted Detection and Diagnosis Software” (CADe + CADx).
- Imagen OsteoDetect (DEN180005: https://www.accessdata.fda.gov/cdrh_docs/pdf18/DEN180005.pdf).
- Classification Product Code: QBS
- Device type: Radiological computer aided triage and notification software.
- Viz.AI ContaCT (DEN170073: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN170073.pdf).
- Classification Prodcut Code: QAS
- Device type: Retinal diagnostic software device
- IDx IDx-DR (DEN180001: https://www.accessdata.fda.gov/cdrh_docs/reviews/DEN180001.pdf).
- Classification Prodcut Code: PIB