Medical Devices

Download Product Code Classification Files

File

This file is replaced every Sunday.

FileFile name
Product Codefoiclass.zip

Back to Top Arrow


Information on How to download

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:

  1. uncompress the file with WinUnzip, PKUnzip, or other utility;
  2. rename file: filename.lis to filename.txt.
  3. If the file is to be imported into a database, each field or Data Element is delimited by a | or pipe.

Back to Top Arrow


File Description

 Data Elements
1Review Panel (2 characters)
2Medical Specialty (2 characters)
3Product Code: 3 character unique product identifier
4Device Name
5Device Class
6Unclassifed Reason Code
7GMP Exempt Flag
8Third Party Review Eligible
9Third Party Review Code
10Regulation number of classification regulation which identifies this device
11Submission Type ID
12Definition

Back to Top Arrow


Medical Specialty

Two letters indicate the medical specialty panel responsible for reviewing the product.

Medical Specialty (Advisory Committee)Regulation No. Medical Specialty Code
AnesthesiologyPart 868AN
CardiovascularPart 870CV
Clinical ChemistryPart 862CH
DentalPart 872DE
Ear, Nose, & ThroatPart 874EN
Gastroenterology & UrologyPart 876GU
General HospitalPart 880HO
HematologyPart 864HE
ImmunologyPart 866IM
MicrobiologyPart 866MI
NeurologyPart 882NE
Obstetrics/GynecologyPart 884OB
OphthalmicPart 886OP
OrthopedicPart 888OR
PathologyPart 864PA
Physical MedicinePart 890PM
RadiologyPart 892RA
General & Plastic SurgeryPart 878SU
Clinical ToxicologyPart 862TX

Back to Top Arrow


Device Name

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.

Back to Top Arrow


Device Class

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

Further information on how devices are classified.

Back to Top Arrow


Regulation Number

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.

Back to Top Arrow


Third Party Review Code

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

Back to Top Arrow


Accredited Persons Eligible

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

Back to Top Arrow


Unclassified Reason Code

Unclassified Reason CodeUnclassified Reason
1Pre-Amendment
2IDE
3For Export Only
4Unknown
5Guidance Under Development
6Enforcement Discretion
7Not FDA Regulated

Back to Top Arrow


Submission Type ID

Submission Type IDSubmission Type
1510(K)
2PMA
3Contact ODE
4510(K) Exempt

Back to Top Arrow

Page Last Updated: 11/04/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.