Why is my 'General Use' massage gun being rejected?

If you select a Medical Device Product Code (e.g., ISA for Therapeutic Massager), the system logic expects a medical Intended Use (081.001). For truly general use items, do not build an FDA Product Code; use Disclaimer A instead.

Can I use Intended Use Code 970.000 (Import for Export) to store goods?

No. IUC 970.000 requires immediate intent to export and must be accompanied by the 'IFE' Affirmation of Compliance. Using it to 'park' unapproved inventory is a high-risk audit trigger.

FDA Intended Use Logic: Aligning Product Codes & Affirmations

1. Overview

In the FDA's Automated Commercial Environment (ACE), the "PGA Data Mismatch" (Error 108) stands as the primary barrier to automated clearance. This error occurs not because data is missing, but because the logical relationship between the Product Code (Record PG02) and the Intended Use Code (Record PG01) is invalid. For the "FDA Product Code Builder" agent, understanding this relationship is critical: a syntactically correct Product Code is useless if paired with an Intended Use Code that contradicts the commodity's regulatory definition.

With the release of FDA Supplemental Guide Draft Version 2.5.12 (2025), the stakes have escalated. Commodities previously allowed to file with generic "Unknown" statuses—specifically Cosmetics, Ceramicware, and Pharmaceutical Necessities—now face mandatory Intended Use Code (IUC) requirements. This workpaper defines the decision logic required to align what a product is with how it is used, preventing high-risk audit flags and systemic rejections.

2. Key Concepts

To construct a valid PGA Message Set, the "Builder" agent must navigate three interdependent data elements. These form the "Triangle of Compliance."

The Regulatory Trinity

The Product Code (PG02): Defines the "What." It establishes the inherent regulatory identity of the goods (e.g., "Vinyl Examination Gloves"). It sets the hard constraints for what uses are legally possible.
The Intended Use Code (IUC) (PG01): Defines the "Why." It declares the objective intent of the import (e.g., "For Medical Use" vs. "For Commercial Processing"). This code is the primary switch that triggers specific data requirements.
Affirmation of Compliance (AofC) (PG23): Defines the "Proof." These are the license numbers (e.g., Registration, Listing, PMA) required to validate the claim made by the Intended Use Code.

The "General Use" Binary

Regulated Use: The product requires FDA oversight. You must submit a full PGA Message Set with a valid IUC (e.g., 081.001 for Devices) and matching AofCs.
General Use (Disclaimer A): The product falls under an FDA-flagged tariff but is not used for FDA-regulated purposes. Crucial Logic: You cannot use Disclaimer A if the Product Code you selected implies a regulated function (e.g., you cannot select a "Surgical Instrument" Product Code and then Disclaim it; you must not build an FDA Product Code at all for true general use items).

Draft 2.5.12 Mandates (2025 Updates)

Cosmetics (COS): IUC is now Mandatory. (e.g., 110.000 for Trade Show, 210.000 for Personal Use).
Food Contact (CCW): IUC is now Mandatory for Ceramicware and Food Contact Substances (e.g., 130.029).
Pharma Necessities (PHN): IUC is now Mandatory. New code 130.033 added for inactive ingredients/excipients.

3. Core Principles: The Logic Matrix

The "Builder" agent must apply these logic gates to prevent mismatches. The selection of an Industry Code (first two digits of Product Code) restricts the available Intended Use Codes.

Industry Code (PG02)	Valid Intended Use Logic (PG01)	Mandatory Affirmation Trigger (PG23)
73-92 (Medical Devices)	081.001 (Standard Import) 081.007 (Component for Mfg)	If 081.001 → Requires DEV, DFE, LST. If 081.007 → Requires CPT (Component).
50-60s (Drugs)	080.000 (Prescription) 150.007 (API/Bulk)	If 080.000 → Requires DA (NDA/ANDA), REG, DLS. If 150.007 → Requires REG, DLS.
52 (Food Contact)	130.029 (Food Contact Substance) 970.000 (Import for Export)	If 130.029 → Check for AofC (e.g., FCN number if applicable). If 970.000 → Requires IFE.
53 (Cosmetics)	290.000 (Standard Commercial) 210.000 (Personal Use)	If 290.000 → COS (Registration) is optional but recommended to lower PREDICT score.

4. Common Issues & Solutions: High-Risk Mismatches

These scenarios represent the most frequent causes of "Error 108" and functional audits due to logic failures in the declaration.

Scenario	The Conflict	The Logic Solution
Dual-Use: Massage Guns	Risk: Declaring a "Therapeutic Massager" (Product Code ISA / Reg 890.5660) as "General Use" (Disclaimer A). Reality: If the label claims "Therapeutic," it is a device.	Logic Check: Does the label say "Therapeutic" or "Pain Relief"? Yes: Use Product Code ISA + IUC 081.001. No: Do not use FDA Product Code. Disclaim A.
Dual-Use: Vinyl Gloves	Risk: Importing "Vinyl Exam Gloves" (Product Code LYZ) with IUC "General Use." Reality: "Exam" implies medical grade. "Industrial" implies general use.	Logic Check: Are they for medical exams? Yes: Code LYZ + IUC 081.001 + LST/DEV. No: Disclaim A. (Do not build a Medical Device Product Code).
Chemicals: Isopropyl Alcohol	Risk: Declaring Bulk API (PIC 'S') with IUC for Finished Product (080.000). Reality: Mismatch between "Bulk" status and "Finished" intent.	Logic Check: Is this for manufacturing or retail sale? Mfg (API): PIC 'S' + IUC 150.007. Retail (OTC): PIC 'F' + IUC 130.000.
Import for Export (IFE)	Risk: Using IUC 970.000 to "park" unapproved goods without export intent. Reality: Illegal storage.	Logic Check: User selects IUC 970.000. System Must Force: Affirmation IFE + Bond Verification.

5. Quick Reference: Critical Codes (2025)

Use these codes to configure the default logic paths for the Agent.

081.001 — Standard Medical Device Import. Requires: DEV, LST, DFE.
150.007 — Bulk Drug Substance (API) for processing. Requires: Manufacturer REG.
130.029 — Food Contact Substance (Chemicals/Additives). Note: Distinct from finished housewares.
130.033 — Inactive Ingredients / Excipients (Pharmaceutical Necessities).
970.000 — Import for Export. Red Flag: High Audit Risk. Requires IFE Affirmation.

6. Interactive Tool: The Logic Builder Protocol

Use this tool to walk through the FDA Product Code Builder decision tree. Describe your product below to determine the correct Product Code, Intended Use Code, and required Affirmations of Compliance.

Decision Logic Tool

FDA Logic Builder Protocol

Describe your product and its intended use to determine the correct Product Code, Intended Use Code (IUC), and required Affirmations of Compliance.

Mirrors the FDA Product Code Builder logic protocol

Logic Builder Result

Describe your product to determine the correct PG01/PG02/PG23 combination.

Demo output only; not a substitute for FDA rulings or legal review.

7. Implementation Guide

Use this checklist to validate the final PGA Message Set before transmission.

Validation Checklist

Product Code vs. Disclaimer: If you have a valid 7-digit FDA Product Code, you CANNOT file Disclaimer A. You must file a full message set.
Product Code vs. IUC: Does the Industry Code (first 2 digits) match the IUC category? (e.g., Industry 57 cannot use IUC 210.000 [Food Personal Use]).
IUC vs. Affirmation: If IUC = 081.001, are DEV, DFE, and LST present? If IUC = 970.000, is IFE present?

Audit Warning

Personal Use Abuse (210.000): Do not use this code for commercial quantities. FDA PREDICT algorithms flag repeated use of 210.000 to the same address as "Structuring/Smuggling."
Research Use (180.xxx): Only use if the consignee is a valid research institution or corporate lab. Home addresses using this code are automatically flagged for physical exam.

8. Additional Resources

FDA Supplemental Guide 2.5.12: Definitive source for the new 2025 mandatory IUCs. [1]
FDA Product Code Builder: Official tool for generating the 7-character PG02 code. [2]
PGA Error Dictionary: Reference for troubleshooting "Error 108" and related rejections. [3]