United States Product Registration & Certification
Important Notes
- Pre-determined Classification & Pathway: Accurately determine FDA regulatory class (e.g., Device Class I/II/III) and corresponding market access pathway (510(k)/PMA/NDA). An incorrect pathway leads to complete project failure.
- Entity Responsibility & Registration: Identify the U.S. responsible entity (Agent/Importer) and complete mandatory FDA Establishment Registration and Product Listing as a prerequisite for legal marketing.
- Quality System Compliance: Establish and maintain a quality system compliant with FDA regulations (e.g., 21 CFR Part 820 QSR, Part 111 cGMP), ready for inspection, as the legal foundation for manufacture and import.
- Evidence-Driven Compliance: Substantiate all ingredient safety and product efficacy claims with adequate, reliable scientific evidence, adhering to strict FTC/FDA labeling and advertising requirements.
US Specific Requirements
- Global Gold Standard: FDA approval or compliance status is the world‘s most recognized endorsement of safety and efficacy, providing immense credibility leverage and negotiation advantages for global market expansion.
- Risk-Tiered Regulation: Regulatory rigor is precisely calibrated to product risk, creating a sophisticated ecosystem from “pre-market approval” to “notification and post-market surveillance,” with clear accountability.
- Predictability Meets High Cost: The User Fee Act mandates statutory timelines for key reviews, but this is coupled with some of the world‘s highest R&D, compliance, and potential litigation costs.
- Strong Enforcement & Litigation Risk: Aggressive FDA/FTC enforcement, combined with high consumer awareness and a class-action-friendly legal system, demands top-tier proactive compliance and robust risk management from companies.
Medical Devices Registration
Regulatory Requirements
- FDA Establishment Registration and Device Listing
- Classification Management by Risk Level (Class I, II, III)
- 510(k), PMA or De Novo Registration Pathway
- QSR 820 Quality System Regulation Compliance
- Unique Device Identification (UDI) Implementation
- Technical Documentation and Test Reports
- Clinical Data (if applicable)
- Biocompatibility Testing (if applicable)
Main Process
- Product Classification Determination
- Predicate Device Identification
- Technical Documentation Preparation
- Testing and Verification Completion
- FDA Application Submission
- Establishment Registration and Listing
Registration Timeline
8-24 months
Official Fees
$10,000 - $500,000+
Service Fees
$25,000 - $150,000
Regulatory System Overview
CDRH
Center for Devices and Radiological Health
Responsible for medical device evaluation, regulation, and market access, including approval of 510(k), PMA, De Novo registration pathways
CFSAN
Center for Food Safety and Applied Nutrition
Responsible for regulation of cosmetics, dietary supplements, and food, including VCRP registration, NDI notification review
OC
Office of Compliance
Responsible for establishment registration, product listing, quality system inspections, market surveillance and enforcement actions
Medical Devices Registration Process
Product Classification Determination
Determine medical device risk classification (Class I,II,III) and applicable registration pathway
Predicate Device Analysis
Identify substantially equivalent legally marketed device (510(k) pathway)
Technical Documentation Preparation
Prepare complete technical documentation including performance testing, biocompatibility, software validation
Quality System Establishment
Establish quality management system compliant with 21 CFR Part 820
FDA Application Submission
Submit 510(k), PMA or De Novo application, complete establishment registration and device listing
Cosmetics Registration
Regulatory Requirements
- Voluntary Cosmetic Registration Program (VCRP)
- Ingredient Safety Substantiation Responsibility
- Labeling Compliance Requirements (FPLA)
- Good Manufacturing Practice (GMP)
- Accurate Ingredient Declaration
- Safety Substantiation Documentation
- Adverse Event Reporting System
Main Process
- Ingredient Safety Assessment
- Labeling Compliance Review
- Establishment Information Registration
- VCRP Voluntary Registration
- GMP System Establishment
Registration Timeline
2-6 months
Official Fees
Free
Service Fees
$8,000 - $25,000
Regulatory System Overview
CDRH
Center for Devices and Radiological Health
Responsible for medical device evaluation, regulation, and market access, including approval of 510(k), PMA, De Novo registration pathways
CFSAN
Center for Food Safety and Applied Nutrition
Responsible for regulation of cosmetics, dietary supplements, and food, including VCRP registration, NDI notification review
OC
Office of Compliance
Responsible for establishment registration, product listing, quality system inspections, market surveillance and enforcement actions
Cosmetics Registration Process
Ingredient Safety Assessment
Comprehensively assess safety of all cosmetic ingredients, prepare safety substantiation documentation
Labeling Compliance Review
Ensure labeling complies with Fair Packaging and Labeling Act (FPLA) requirements
VCRP Voluntary Registration
Submit Voluntary Cosmetic Registration Program, register establishment and product information
GMP System Establishment
Establish good manufacturing practice system meeting FDA expectations
Adverse Event Monitoring
Establish serious adverse event monitoring and reporting system
Dietary Supplements Registration
Regulatory Requirements
- New Dietary Ingredient (NDI) Notification
- cGMP Regulation Compliance (21 CFR 111)
- Structure-Function Claims Compliance
- Labeling Requirements per DSHEA
- Serious Adverse Event Reporting System
- Ingredient Specification and Purity Proof
- Product Stability Data
Main Process
- Ingredient Compliance Assessment
- NDI Notification Submission
- cGMP System Establishment
- Label Claims Review
- Adverse Event System Establishment
Registration Timeline
4-12 months
Official Fees
$500 - $5,000
Service Fees
$12,000 - $35,000
Regulatory System Overview
CDRH
Center for Devices and Radiological Health
Responsible for medical device evaluation, regulation, and market access, including approval of 510(k), PMA, De Novo registration pathways
CFSAN
Center for Food Safety and Applied Nutrition
Responsible for regulation of cosmetics, dietary supplements, and food, including VCRP registration, NDI notification review
OC
Office of Compliance
Responsible for establishment registration, product listing, quality system inspections, market surveillance and enforcement actions
Dietary Supplements Registration Process
Ingredient Compliance Assessment
Evaluate all ingredients for compliance with Dietary Supplement Health and Education Act (DSHEA)
NDI Notification Submission
Submit NDI notification to FDA 75 days in advance if using new dietary ingredients
cGMP Compliance
Establish current good manufacturing practice system compliant with 21 CFR Part 111
Label Claims Review
Ensure all structure-function claims comply with FDA requirements, avoid drug claims
Quality Control System
Establish complete quality control, testing and documentation system