FDA Certification – A Complete Overview
Mandatory U.S. FDA registration and compliance process for exporting food, drugs, cosmetics, medical devices and other regulated products under the Federal Food, Drug, and Cosmetic Act.
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Overview of FDA Certification
The U.S. Food and Drug Administration (FDA), established in 1906, regulates food, drugs, cosmetics, medical devices, veterinary products, tobacco and radiation devices. Exporters must register facilities, comply with Current Good Manufacturing Practices (CGMP), and pass FDA inspections, documented by Form 483 and Establishment Inspection Reports (EIR), to gain market access in the United States.
Additional Regulatory Bodies
Key organizations complementing the FDA include: • CDRH (Center for Devices and Radiological Health) – regulates medical devices and radiation‑emitting products. • IEC (International Electrotechnical Commission) – sets global electrotechnology standards. • ANSI (American National Standards Institute) – oversees U.S. voluntary consensus standards across industries.
Types of Products & Approvals
• Food Facilities: Register with FDA; comply with CGMP; no pre‑approval of food itself. • Drugs: OTC monograph drugs bypass approval; new drugs require NDA. • Cosmetics: No pre‑market approval (unless making drug claims). • Color Additives: Batch certification required for certain additives. • Medical Devices: Class I (low risk, often 510(k)‑exempt), Class II (510(k) submissions), Class III (PMA).
Key Benefits of FDA Certification
1. Industry Impact: Global mark of safety and quality. 2. Consumer Confidence: Drives demand and trust. 3. Market Access: Enables export with Certificate of Foreign Government. 4. Brand Credibility: Enhances reputation among stakeholders. 5. Product Development: Improves processes via CGMP. 6. Funding Access: Attracts investors and partnerships. 7. Healthcare Distribution: Access to hospitals, pharmacies, and clinical trials.
Extended Advantages
• Easier Access to Investment and Funding: Many investors seek FDA‑approved products. • Recognition in Medical and Healthcare Networks: Hospitals and clinics prefer FDA‑cleared products. • Expansion into New Markets: CFG enables entry into Japan, Brazil, Australia, China. • Process Improvement: Focus on safety and efficacy from R&D through manufacturing.
1. Documents Required for FDA Registration
Entry Documentation: Bill of Lading, Airway Bill, Commercial Invoice, Purchase Order.
Commodity‑Specific: Packing List, Growers List (for produce), Labeling Copies, Ownership Documentation, Statement of Intended Use, plus any additional product‑specific paperwork requested by FDA.
Step‑by‑Step FDA Certification Process
1. Facility Inspection by FDA to assess CGMP compliance.
2. Issuance of Form 483 listing inspection observations.
3. Submit written response to Form 483 within 15 working days with corrective action plan.
4. FDA issues Establishment Inspection Report (EIR) outlining need for enforcement.
5. If observations are inadequate or severe, FDA issues a Warning Letter (sometimes skipping Form 483).
6. Respond to Warning Letter within 15 working days to avoid cancellation of licenses, import alerts, or suspension.
7. Complete pre‑clinical testing, IND, NDA or PMA submissions as required.
8. Final Approval granted once all concerns are resolved and compliance demonstrated.
FDA‑Related Fees & Penalties
While the FDA does not charge for inspections, manufacturers must fund compliance activities. Failure to respond timely to Form 483 or Warning Letters may trigger import alerts, license suspension, product denial, or legal action.
How DoStartup Facilitates Your FDA Certification
1. Consultation with FDA regulatory experts on requirements and timelines.
2. Legal support from FDA‑savvy attorneys for application and inspections.
3. Document preparation and submission via FDA’s Electronic Submission Gateway (ESG).
4. Coordination of Form 483 responses, Warning Letter follow‑ups, and EIR debriefs.
5. Regular status updates and final delivery of certification and CFG issuance.