This file is replaced every Sunday.
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:
- uncompress the file with WinUnzip, PKUnzip, or other utility;
- rename file: filename.lis to filename.txt.
- If the file is to be imported into a database, each field or Data Element is delimited by a | or pipe.
|1||Review Panel (2 characters)|
|2||Medical Specialty (2 characters)|
|3||Product Code: 3 character unique product identifier|
|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|
Two letters indicate the medical specialty panel responsible for reviewing the product.
|Medical Specialty (Advisory Committee)||Regulation No.||Medical Specialty Code|
|Clinical Chemistry||Part 862||CH|
|Ear, Nose, & Throat||Part 874||EN|
|Gastroenterology & Urology||Part 876||GU|
|General Hospital||Part 880||HO|
|Physical Medicine||Part 890||PM|
|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:
- 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
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: Third Party Review
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|
|3||For Export Only|
|5||Guidance Under Development|
|7||Not FDA Regulated|
|Submission Type ID||Submission Type|
|6||HDE - Humanitarian Device Exemption|
|8||EUA - Emergency Use Authorization|