This file is replaced monthly ,usually on the 5th of each month.
File |
File name |
---|---|
Product Code | foiclass.zip |
The data is available in zipped files for downloading. These files were then compressed ("zipped") in order to save space. For these files to be useful to you, you'll first have to download them, unzip them, and then import them into a database or word processor for your further processing.
The general steps for Zip Files are:
Data Elements |
|
---|---|
1 | Review Panel (2 characters) |
2 | Medical Specialty (2 characters) |
3 | Product Code: 3 character unique product identifier |
4 | Device Name |
5 | Device Class |
6 | Unclassifed Reason Code |
7 | GMP Exempt Flag |
8 | Third Party Review Eligible |
9 | Third Party Review Code |
10 | Regulation number of classification regulation which identifies this device |
11 | Submission Type ID |
12 | Definition |
Two letters indicate the medical specialty panel responsible for reviewing the product.
Medical Specialty (Advisory Committee) | Regulation No. | Medical Specialty Code |
Anesthesiology | Part 868 | AN |
Cardiovascular | Part 870 | CV |
Clinical Chemistry | Part 862 | CH |
Dental | Part 872 | DE |
Ear, Nose, & Throat | Part 874 | EN |
Gastroenterology & Urology | Part 876 | GU |
General Hospital | Part 880 | HO |
Hematology | Part 864 | HE |
Immunology | Part 866 | IM |
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 |
The Device Name uses the format of a noun that is usually followed by one or more adjectives, separated by commas. Therefore, the first word in the device name is usually the best search parameter. For example, to find a specific pump, search on the word "pump" to retrieve all products with the word "pump" in their name.
Device Class refers to the level of CDRH regulation of a given device. For each device, the applicable Medical Specialty panel recommends to CDRH the appropriate device class. The three Class designations are:
Further information on how devices are classified can be found at : http://www.fda.gov/cdrh/devadvice/313.html
The CDRH database links medical devices to the appropriate regulation that contains a product definition and is published in Title 21, Code of Federal Regulations. If the database does not reference a regulation number, the device has not yet been classified and the device class listed (1, 2, or 3) is proposed, not final.
This information identifies the Third Party Review Program(s) for which the device is a candidate. The three identifiers are:
A = Candidate for Accredited Persons Program (APP)
M = Candidate for Mutual Recognition Agreement (MRA) Program
B = Candidate for both APP and MRA Programs
When the device is a candidate for Third Party Review under the Accredited Persons program, the following codes reflect whether it became eligible under the preexisting program or the expansions program. Further information on this program can be found at : http://www.fda.gov/cdrh/thirdparty/
Y = Eligible for Accredited Persons Program
N = Not Eligible for Accredited Persons Program
P = Eligible for Accredited Persons Expansion Pilot Program
Unclassified Reason Code | Unclassified Reason |
---|---|
1 | Pre-Amendment |
2 | IDE |
3 | For Export Only |
4 | Unknown |
5 | Guidance Under Development |
6 | Enforcement Discretion |
7 | Not FDA Regulated |
Submission Type ID | Submission Type |
---|---|
1 | 510(K) |
2 | PMA |
3 | Contact ODE |
4 | 510(K) Exempt |
Updated January 11, 2006
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Center for Devices and Radiological Health / CDRH