Specification of FDA Food Contact Materials Testing

The U.S. Food and Drug Administration (FDA) does not issue formal "certifications" but instead regulates products through approvals, clearances, listings, and compliance programs.

FDA Compliance Requirements for Common Products

Food & Beverages

- Facility Registration (Required for domestic/foreign manufacturers)

- Food Safety Modernization Act (FSMA) compliance

- Labeling Rules (Nutrition Facts, allergen warnings)

- GRAS (Generally Recognized as Safe) Approval for additives

- Import Alerts (FDA can detain non-compliant shipments)

Drugs (Pharmaceuticals)

- NDA (New Drug Application) for prescription drugs

- OTC Monograph System for non-prescription drugs

- CGMP Compliance (Current Good Manufacturing Practices)

- Drug Listing & Establishment Registration

Medical Devices

- Class I (Low Risk) – General controls (e.g., bandages)

- Class II (Moderate Risk) – 510(k) clearance (e.g., blood pressure monitors)

- Class III (High Risk) – PMA (Premarket Approval) (e.g., pacemakers)

- FDA Establishment Registration required for all device makers

Cosmetics

- Voluntary Facility Registration (VCRP)

- Prohibited Ingredients (e.g., mercury, certain color additives)

- Labeling Requirements (Ingredient lists, warnings)

How to Comply with FDA Regulations for Food Contact Materials

When we plan to pefrom FDA compiance for our product, we need to determine product classification first: Is it a food, drug, medical device, or cosmetic? Then, in order to meet regulatory requirements we should submit premarket approvals (PMA, 510k, NDA) and comply with CGMP standards. If the product is frugs devices, it needs to proceed clinical trials, and submit some technical files. If the product is food or contaminants, it needs to proceed lab testing. After testing, proceed to FDA submission review and wait for FDA approval.....

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