Medical Devices

Download Product Code Classification Files

File

This file is replaced every Sunday.

File File name
Product Code foiclass.zip

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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.

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File Description

  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
13 Physical State
14 Technical Method
15 Target Area
16 Implant Flag (Y/N)
17 Life Sustain Support Flag (Y/N)
18 Summary Malfunction Reporting (Eligible/Ineligible)

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Medical Specialty

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

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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.

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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.

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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.

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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

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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

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Unclassified Reason Code

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

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Submission Type ID

Submission Type ID Submission Type
1 510(K)
2 PMA
3 Contact ODE
4 510(K) Exempt
6 HDE - Humanitarian Device Exemption
7 Enforcement Discretion
8 EUA - Emergency Use Authorization

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Page Last Updated: 09/24/2018
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