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U.S. Department of Health and Human Services

Medical Devices

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Presentation: Product Codes - Making the Connection….

(This presentation is also available in video format with captioning and PDF printer-friendly format.)

Julie “Brandi” Stuart
Center Product Code Coordinator
Consumer Safety Officer, 510(k) Staff
FDA Office of Evaluation, CDRH

May 28, 1976 Medical Device Amendments Public Law 94-295

The May 28, 1976, Medical Device
Amendments required and led to:

The classification of approximately 1,700 generic device types.

Code of Federal Regulations (CFR) 21 CFR Parts 862-892

Regulations describe the device types as they existed prior to May 28, 1976 (Pre-amendment)

How Do Product Codes Fit In With CFR?


This flow chart mapping shows how a product code is derived. The Code of Federal Regulations (CFR) is organized by panel, such as Radiology Part 892. Each generic device type under this panel is further described under Parts 892 such as 892.1830 Radiological Patient Cradle and a product code, such as ‘KXH’ is created to represent this specific device type.

Product Code: KXH

Screenshot of Product Classification Database displaying information for Product Code KXH

Classification Today & Product Codes

Individual devices are classified by premarket review i.e., 510(k), PMA

New indications for use or new technologies are assigned new product codes that are placed under the original regulation

Preamendment Device Type Described in CFR

872.6865 – Powered Toothbrush
A powered toothbrush is an AC-powered or battery-powered device that consists of a handle containing a motor that provides mechanical movement to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay. Classification: Class 1 Exempt

Product Code Information: JEQ Powered Toothbrush Regulation: 876.6865 Class 1 Exempt

Substantially Equivalent

New Device Type: Ionic Powered Toothbrush
New Technology Required 510(k)
510(k) Found Substantially
Equivalent to Preamendment Device

Product Code Information: MMQ Powered Ionic toothbrush Regulation: 876.6865 Class 1 Exempt

Substantially Equivalent (SE)

 

Why Are Product Codes Important To Me?

Ultimately classify the device Found on all 510(k) & PMA Letters
Tools:

  • Required for Registration & Listing
  • Used to Search for a Predicate
  • Used to Search & Report Adverse Events
  • Used Identify Third Party Eligible Device Types
  • Required When Importing & Exporting Devices
    This Flowchart describes how the pre-amendment regulation is an umbrella and product codes are created to describe the pre-amendment devices such as the ‘JEQ’ product code for a Powered Toothbrush and as new technologies are found substantially equivalent via the 510(k) Program additional post amendment product codes are added under the regulation 872.6865 such as the product code ‘MMQ’ for an Ionic Powered Toothbrush. This process is repeated as new technologies are introduced into the marketplace.
Why Are Product Codes Important To Me?
  • Product Codes Ultimately Classify Your Device
  • Found on all 510(k)and PMA Letters
Substantially Equivalent (SE) Letter:

Product Codes are on all SE Letters and are available on the Internet. All decision letters of this type include the product code directly on the letter and this is the official classification of the device type.
 

Registration and Listing

A firm can ONLY list with the product code found on their 510(k) or PMA Clearance/Approval Letter

Unless registering with a . . . . . .

  • Class 1 Exempt Device
  • Class 2 Exempt Device
Search For Predicates

http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfPMN/pmn.cfm

Adverse Event Reporting

http://www.accessdata.fda.gov/scripts/ cdrh/cfdocs/cfMAUDE/search.CFM

Search For Third Party Eligible Device Types

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfThirdParty/current.cfm#4

Classification Database

http://www.accessdata.fda.gov/ scripts/cdrh/cfdocs/cfPCD/ classification.cfm

Product Code Descriptions


Screenshot of Product Classification Database showing the product code description for Product Code NOP

Classification Database

Provides:

Links to Standards;
Links to Associated Guidance Documents;
Product Code Definitions and Indications for Use Fields;
Expanded Descriptions; and
Third Party Eligibility

Contact

 

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