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MA128 Remark Code: FDA Approval Number Missing

MA128 means the claim was missing, or had an incomplete or invalid, FDA approval number. Payers ask for it when coverage depends on the item's FDA status, such as certain devices.

Quick facts

Code
MA128 (RARC MA128)
Status
Active In use since October 12, 2001; last modified March 30, 2005.
Code set
Remittance Advice Remark Codes (RARC)
Group codes
  • CO (Contractual Obligation): The item was not paid because the FDA number was missing or invalid. The provider corrects it; the patient is not billed.
Official description
Missing/incomplete/invalid FDA approval number.
X12 Remittance Advice Remark Codes, retrieved September 25, 2026
Last verified
against the official X12 list.

What MA128 means

Coverage for some items, especially medical devices, depends on their FDA status. MA128 tells you the payer needed an FDA approval number for the item on the claim and it was missing, incomplete, or invalid. The payer cannot confirm the item is FDA approved or cleared without it.

It usually comes with CARC 16.

Common causes

  • The payer requires an FDA number for the device billed and none was reported.
  • A model or catalog number was entered instead of the FDA number.
  • The number was placed in a field the payer does not read.
  • The item is investigational, and an investigational device exemption number was needed instead.

How to fix it

  1. Get the FDA number for the item from the manufacturer or FDA databases.
  2. Report it in the field the payer specifies.
  3. Check for investigational status; if applicable, report the IDE number (see MA50).
  4. Resubmit the corrected claim, using resubmission code 7 with the original claim number in item 22 when replacing a processed claim.

How to prevent it

  • Keep a device master list with FDA numbers linked to the HCPCS codes you bill.
  • Review payer policies for devices requiring FDA numbers on claims.
  • For more on data errors, see CO-16 missing information denials.

Codes that may appear with MA128

  • CO-16 (Claim/service lacks information or has submission/billing error(s).): The claim is missing information needed for adjudication, here the FDA approval number.
  • CO-114 (Procedure/product not approved by the Food and Drug Administration.): The procedure or product is not approved by the FDA, which may follow if the number cannot be validated.
  • MA50 (Missing/incomplete/invalid Investigational Device Exemption number or Clinical Trial number.): A missing or invalid investigational device exemption number or clinical trial number.
  • MA97 (Missing/incomplete/invalid Medicare Managed Care Demonstration contract number or clinical trial registry number.): A missing managed care demonstration contract or clinical trial registry number.

MA128 FAQ

What FDA number is needed?

It depends on the item and payer. Payers may request an FDA approval number, such as a premarket approval or clearance number, for devices or items where coverage depends on FDA status.

Where do I find the number?

From the manufacturer or FDA's public device databases. Keep a copy with your item records.

Where does it go on the claim?

Payers specify the field, often the claim note or item 19 on paper claims. Check the payer's instructions.