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Please note: as of October 1, 2002, FDA charges fees for review of Premarket Notification 510(k)s and Premarket Approvals
Most medical devices can be classified by finding the matching description
of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892.
FDA has classified and described over 1,700 distinct types of devices and organized
them in the CFR into 16 medical specialty "panels" such as Cardiovascular
devices or Ear, Nose, and Throat devices. These panels are found in Parts 862
through 892 in the CFR. For each of the devices classified by the FDA the CFR
gives a general description including the intended use, the class to which the
device belongs (i.e., Class I, II, or III), and information about marketing
requirements. Your device should meet the definition in a classification regulation
contained in 21 CFR 862-892.
868
Anesthesiology
870
Cardiovascular
862
Clinical Chemistry and Clinical Toxicology
872
Dental
874
Ear, Nose, and Throat
876
Gastroenterology and Urology
878
General and Plastic Surgery
880
General Hospital and Personal Use
864
Hematology and Pathology
866
Immunology and Microbiology
882
Neurology
884
Obstetrical and Gynecological
886
Ophthalmic
888
Orthopedic
890
Physical Medicine
892
Radiology
If your device requires premarket notification [510(k)] proceed to the Premarket
Notification [510(k)] page. For Class I devices exempt from [510(k)] the submission of a
[510(k)] and marketing clearance from FDA is not required. If your Class I (or certain
class II) device is exempt, subject to the limitations on exemptions, from the 510(k)
process, this will be stated in the classification regulation. However, other General
Controls such as registration, listing,
labeling, and good manufacturing
practices apply. If you have a Class III device requiring premarket approval (PMA)
proceed to Premarket Approval (PMA) page.
You can also check the Precedent Correspondence for
information on how various products are regulated by CDRH.
Market submission options
510(k)
PMA
Exempt
Updated June 10, 2003
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