FDA Compliant Coating Solutions
This class of FDA complaint powder coatings are available for your medical (including intra-body), food grade or food contact requirements. The FDA supplies a list of raw materials that can be used in the manufacture of FDA compliant coatings. If the manufacturer uses only these listed raw materials in the formulation of their powder coatings, the manufacturer can market them as FDA compliant coatings.
Understanding FDA Compliance vs. FDA Approval
Andrews Powder Coating, Inc., is a supplier of compliant powder coatings, and a professional applicator as well. It should be noted that no FDA compliant powder coating comes with a blanket FDA approval.
FDA approval only occurs after the completed assembly has been coated and then submitted to a third-party laboratory for testing to the FDA requirements of 510(k), ISO 10993, or ISO 13485.
Only after this testing, and subsequent submission to the FDA, can a product be called FDA approved. Certificates of Compliance (CoC) are provided for these applications.
Ensure Compliance with Confidence
Take the first step in ensuring your coated products meet food-grade FDA standards. Contact us below for a free quote and to learn more about our FDA-compliant powder coatings.
FAQ About Our FDA Compliant Coatings Services
Below are answers to the most frequently asked questions regarding our FDA compliant coating services and regulatory requirements.
What is the exact difference between “FDA compliant” and “FDA approved”?
“FDA compliant” means the coating meets FDA regulations, such as Current Good Manufacturing Practices (cGMP) or food contact material standards (e.g., 21 CFR 175.300), without needing premarket approval. This applies to food-grade, food-contact, or low-risk medical device coatings (Class I or II).
As our FDA-compliant coatings are not formally evaluated by the FDA, you, the manufacturer, must ensure compliance by integrating the coated component into your legally compliant Quality Management System (QMS) and completing the necessary steps for final FDA submission. This is typically done through submission, testing and qualification by a third party laboratory.
FDA compliant coatings are formulated with raw materials that are deemed safe by the FDA. These materials have undergone rigorous FDA review and authorization, confirming their safety and efficacy for specific uses, such as coatings for all forms of medical devices including Class III medical implants. Learn more about premarket approval for Class III devices. Food contact is also an area that is well served by powder coating applications. It should be noted that some coatings are sensitive to high temperature autoclave disinfection. Testing and possible non-traditional sterilization may be required.
What is a Certificate of Compliance (CoC) and what information does it contain?
A Certificate of Compliance (CoC) for FDA-compliant coatings, such as those supplied by Andrews Powder Coating, Inc. for medical, food-grade, or food-contact uses, is a document we issue to confirm that the coating adheres to relevant FDA regulations and standards, ensuring safety and suitability for its intended application.
The CoC serves as a formal declaration that the coating complies with relevant FDA requirements, such as those outlined in the Code of Federal Regulations (e.g., 21 CFR 175.300 for food-contact coatings or Current Good Manufacturing Practices for medical device coatings).
What types of materials and dimensions can you coat?
Andrews Powder Coating coats all forms of metal that can withstand approximately 200°C (392°F), including:
Titanium
Stainless steel
Aluminum
Steel
Nickel
Some non-metallic substrates may also be coated, but these require specifically designed systems. Please contact us for further information on metallic or non-metallic substrates.
What is your typical turnaround time for a project?
Our typical lead time is 7–10 working days: this is dependent on the specific project’s size and complexity.
What information do I need to provide to get a quote?
To request a detailed written quote, please email info@powdercoater.com. Ensure your message includes complete contact information:
Full name and contact telephone number
Business name (if applicable)
Address