List of Devices for Third Party Review under the FDA Modernization Act of 1997
This page identifies the list of devices eligible for 510(k) review or type examination under the Mutual Recognition Agreement (MRA). The list contains the classification names of the medical devices, corresponding section numbers in the 21 Code of Federal Regulations (CFR), three letter product classification codes, and the device class. Most importantly, the far right column references guidance or standards appropriate to the particular medical device, whether specific guidance for the device exists, or general guidance in the absence of specific guidance. The text in this column is a hyperlinked; when viewed in a browser with an Internet connection, double clicking on the text will open up the applicable page(s) of guidance on the FDA site.
Please note that a modification of this list is currently under consideration by the European Commission.
- Clinical Chemistry
- Ear Nose & Throat
- General & Plastic Surgery
- General Hospital
- Physical Medicine