FDA Medical Device Product Code

An FDA medical device product code is a three-letter code that FDA's Center for Devices and Radiological Health (CDRH) assigns to a generic category of device. FDA's Product Code Classification Database page puts it this way: "The name and product code identify the generic category of a device for FDA." The code is assigned "based upon the medical device product classification designated under 21 CFR Parts 862-892" (FDA, Product Code Classification Database).

Approach: I used FDA's CDRH Product Classification database and FDA's page on its 2013 guidance, Medical Device Classification Product Codes. The guidance PDF link returned an error, so the guidance points below come from FDA's summary page for that document.

What the guidance says (FDA guidance page, issued April 11, 2013):

• Purpose: product codes are "a method of internally classifying and tracking medical devices."
• Structure: for CDRH devices and some CBER-regulated devices, the code is "a 3 letter combination which associates a device's type with a product classification." Some other areas use different formats:
  • FDA's import programme uses seven-digit codes that cover devices, foods, drugs, biologics and cosmetics.
  • Licensed biological devices under CBER use a six-character code.
• How a code is assigned: a device gets an existing product code "when it has the same intended use, indications for use, and relies on technology that does not raise new safety and effectiveness questions."
• Where it is used:
  • Establishment registration and device listing: the manufacturer identifies the right code before listing.
  • Premarket submissions: the applicant proposes a code based on the predicate device, and FDA reviewers check it and may assign a different one.
  • Adverse event reporting.
  • Post-market work such as recalls, import and export tracking, and compliance monitoring.

What a product code record holds (example: PZW). Each code in the database is tied to a set of regulatory attributes. Code PZW, "Catheter Access Cover, Tamper-Resistant", carries ^[1]:

• Device class 2
• 21 CFR regulation number 880.5970
• Review panel: General Hospital
• Submission type: 510(k)
• Premarket review office: DHT3C
• A device definition
• Flags for GMP exemption, third-party review eligibility, implant status, life-sustaining/supporting status and eligibility for summary malfunction reporting (here: not GMP-exempt, not third-party eligible, not an implant, not life-sustaining, and ineligible for summary malfunction reporting)

In practice, finding the right product code tells you the device's class, its governing regulation and its likely premarket pathway. It is also the code you use for listing, submissions and reporting.

If you describe your device, I can look up the candidate product codes and compare their class and submission requirements.