Last updated: May 20, 2025
Key Takeaways
- Error 996 is a syntax failure (Static Identification) often caused by missing hyphens or illegal characters.
- Error 108 is a logic failure (Relational Context) caused by a mismatch between Product Code, Intended Use, and Affirmations.
- Resolution requires aligning the 'Trinity of Validation': Product Code (PG02), Intended Use (PG01), and Affirmation of Compliance (PG23).
1. Overview
The transition of US import infrastructure to the Automated Commercial Environment (ACE) has operationalized regulatory law into binary code. Unlike the previous system, ACE functions as a rigorous, real-time validation engine. Shipments are not merely flagged for review; they are actively rejected if data does not strictly conform to the FDA's internal business rules. This creates "fatal" errors that freeze the supply chain at the port of entry.
The two most pervasive impediments are Error 996 (Invalid Product Code) and Error 108 (PGA Data Mismatch). Error 996 represents a failure of Static Identification—the system cannot identify what the product is due to syntax or reference table failures. Error 108 represents a failure of Relational Logic—the system identifies the product but finds the surrounding data context (Intended Use, Compliance Affirmations) to be mutually exclusive or legally incoherent.
2. Key Concepts
Resolving these errors requires an absolute command of the FDA Product Code structure—a hierarchical 7-character string where every position determines the validation logic for the next.
Structural Components
- Industry Code (Positions 1-2): A numeric root (02-98) determining the broad category (e.g., 53=Cosmetics, 80=Medical Devices). Non-numeric characters here trigger immediate rejection.
- Class Code (Position 3): A single alpha character (A-Z) refining the category. Its validity is strictly dependent on the Industry Code (e.g., Class 'L' is valid for Devices but invalid for Bakery products).
Formatting Rules
- The Hyphen Rule (Positions 4-5): For commodities like Medical Devices that lack specific Subclass or Process codes, these positions must be populated with hyphens (e.g.,
79L--RR). Leaving them blank or using spaces causes length validation failures. - Character Integrity: The string must be exactly 7 characters. Common pitfalls include the "OCR Trap"—confusing the letter 'O' with the digit '0' in the Industry segment.
Validation Logic
- Static Identification (Error 996): Triggers when the character string in the
PG02record does not map to a valid entry in the FDA's master ontology or violates structural rules. - Relational Logic (Error 108): Triggers when the "Trinity of Validation"—Product Code, Intended Use Code (IUC), and Affirmation of Compliance (AofC)—is incoherent (e.g., claiming "Research" use without an Investigational Device Exemption number).
3. Core Principles
ACE validation is algorithmic, not interpretive. To clear a shipment, the data must pass two distinct layers of scrutiny: Syntactic Integrity and Contextual Coherence.
| Principle | Description | Application |
|---|---|---|
| Syntactic Integrity (Error 996) | The alphanumeric string must exactly match the length, format, and hierarchy defined in the FDA database. | Ensure the transmitted code is exactly 7 characters. For Devices, verify the -- padding. For Food, verify the specific Packaging Subclass (e.g., 'C' for Metal) is used instead of a hyphen. |
| Contextual Coherence (Error 108) | The Product Code, Intended Use Code (IUC), and Affirmation of Compliance (AofC) must tell a consistent regulatory story. | If IUC is 180.009 (Research), you must provide an AofC of IND or IDE. If IUC is 081.001 (Standard Device Import), you must provide LST (Listing) and DEV (Registration). |
4. Common Issues & Solutions
The following scenarios represent the most frequent causes of fatal rejections in the ACE/FDA environment.
| Issue | Cause | Solution |
|---|---|---|
| Error 996: Invalid Product Code | Syntax errors such as missing hyphens (e.g., 79LRR instead of 79L--RR), illegal characters ('O' vs '0'), or using a retired code from a stale Parts Master. |
Validate the string length is exactly 7. Ensure Pos 4-5 are hyphens if required. Cross-reference the code against the live FDA Product Code Builder to ensure it is active. |
| Error 108: PGA Data Mismatch | Missing Mandatory AofC. The Intended Use Code (e.g., Research) requires specific regulatory permits (e.g., IDE/IND numbers) which were omitted from the PG23 record. | Align the PG23 record with the PG01 Intended Use. Add the required Registration (DEV), Listing (LST), or Exemption (IND/IDE) number that corresponds to the declared use. |
5. Quick Reference
Industry-specific triggers to watch for when debugging rejections:
- Medical Devices (Industry 73-96) — Almost always require hyphens in Pos 4-5. Standard imports (IUC 081.001) mandate both LST (Listing) and DEV (Foreign Manufacturer Registration).
- Biologics (Industry 57) — strict dependency on Intended Use. IUC 080.000 (Licensed) requires a Biologics License Number (BLN) or Submission Tracking Number (STN).
- Food (Industry 02-42) — Packaging Subclass (Pos 4) is often mandatory (e.g., 'C' for Metal), meaning hyphens here will trigger Error 996. Acidified foods (PIC 'E'/'I') trigger Error 108 if FCE/SID are missing.
6. Interactive Tool
The FDA Product Code Builder is the definitive "Source of Truth" for resolving Error 996. It is an online agent that allows users to build the 7-character code step-by-step.
When facing a rejection, do not rely on your internal software's description. Re-build the commodity in the Builder. If the generated code differs from your stored code (e.g., a Class change from 'A' to 'B'), update your system immediately. This validates whether a code has been retired or reclassified.
FDA Product Code Debugger
FDA Product Code 996/108 Debugger
Paste Product Code, Intended Use Code, and Affirmations of Compliance to simulate ACE FDA Error 996/108 logic before filing.
Mirrors ACE Error 996/108 validation logic
Mini-Agent Insight
Submit shipment blocks to see whether ACE would treat them as valid or trigger Error 996/108.
Demo output only; not a substitute for CBP or FDA rulings or legal review.
7. Implementation Guide
Follow this standard operating procedure to systematically resolve ACE rejections:
Diagnosis & Debugging
- Inspect Raw Data (PG02): Verify the Product Code string in the EDI transmission is exactly 7 characters, left-justified, with no trailing spaces, and uses the correct Qualifier (
FDP). - Validate Hierarchy: Check if the Class Code (Pos 3) is valid for the Industry (Pos 1-2). Common errors involve using Cosmetic classes (Ind 53) for Color Additives (Ind 50).
- Audit the "Trinity": For Error 108, map the Product Code to the Intended Use Code (PG01), and ensure the resulting mandatory Affirmations (PG23) are present and match the Manufacturer declared in PG19.
Strategic Prevention
- Master Data Audit: Periodically scrub your "Parts Master" database against the FDA Product Code Builder to identify and remove retired or invalid codes before they trigger rejections.
- Pre-define the "Trinity" in your compliance software: link every Item Number to a specific valid Product Code, a Standard Intended Use, and the specific AofC types (e.g., DEV, LST) required for that combination.
8. Additional Resources
- CBP ACE CATAIR FDA Supplemental Guide: The definitive technical specification for formatting PG records and understanding validation rules.
- FDA Product Code Builder: The official online tool for generating and validating the 7-character alphanumeric commodity codes.
- ACE Error Dictionary: A lookup reference for specific rejection codes (like 108 and 996), providing narrative explanations and related segments.
Frequently Asked Questions
What causes Error 996 on Medical Devices?
The most common cause is missing hyphens in positions 4 and 5. Devices typically require a format like '79L--RR'.
Why do I get Error 108 for Research samples?
If you declare Intended Use Code 180.009 (Research), you must provide an Affirmation of Compliance (PG23) with an IND or IDE number, or a specific exemption code.