List of Devices for Third Party Review under the FDA Modernization Act of 1997
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List
of Devices for MRA Review
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.
- Anesthesiology
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- Cardiovascular
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- Clinical Chemistry
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- Dental
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- Ear Nose & Throat
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- Gastroenterology
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- General & Plastic Surgery
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- General Hospital
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- Hematology
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- Immunology
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- Microbiology
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- Neurology
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- Obstetrics/Gynecology
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- Ophthalmic
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- Orthopedic
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- Pathology
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- Physical Medicine
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- Radiology
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- Toxicology
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Section No. |
Regulation Name Product Code-Device Name |
Class |
Relevant Guidance/Standard |
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