1 - 510(K)
2 - PMA
3 - Contact ODE
4 - 510(K) Exempt
HDE - Humanitarian Device Exemption
Enforcement Discretion
EUA - Emergency Use Authorization
A = Candidate for Accredited Persons Program (APP)
B = Candidate for both APP and MRA Programs
M = Candidate for Mutual Recognition Agreement (MRA) Program
N = Not Eligible for Accredited Persons Program
P = Eligible for Accredited Persons Expansion Pilot Program
Y = Eligible for Accredited Persons Program
Pre-Amendment
IDE
For Export Only
Unknown
Guidance Under Development
Not FDA Regulated
Class 1 - Devices subject to General Controls
Class 2 - Devices subject to General Controls and Special Controls
Class 3 - Devices subject to General Controls, Special Controls, and Premarket Clearance
Not Classified
Unclassified
Anesthesiology Part 868 AN
Clinical Chemistry Part 862 CH
Cardiovascular Part 870 CV
Dental Part 872 DE
Ear, Nose, & Throat Part 874 EN
Gastroenterology & Urology Part 876 GU
Hematology Part 864 HE
General Hospital Part 880 HO
Immunology Part 866 IM
Molecular Genetics MG
Microbiology Part 866 MI
Neurology Part 882 NE
Obstetrics/Gynecology Part 884 OB
Ophthalmic Part 886 OP
Orthopedic Part 888 OR
Pathology Part 864 PA
Physical Medicine Part 890 PM
Radiology Part 892 RA
General & Plastic Surgery Part 878 SU
Clinical Toxicology Part 862 TX