Certification Introduction
For medical devices to enter the U.S. market, they are subject to regulation by the U.S. Food and Drug Administration (FDA). Market access is managed through a classification-based approach according to product risk levels, and obtaining FDA compliant access is a necessary prerequisite for the legal sale of products in the U.S. market.
Laws and Regulations
The core regulatory basis is the Federal Food, Drug, and Cosmetic Act (FD&C Act), implemented together with the QSR 820 Quality System Regulation issued by FDA, as well as the corresponding procedural rules for 510(k) Premarket Notification and PMA Premarket Approval. All medical devices must complete FDA facility and product registration, and low-risk products can be exempted from certain premarket review requirements.
Technical Requirements
- FDA classifies medical devices into Class I (low risk), Class II (medium risk), and Class III (high risk) based on risk, with different market access requirements corresponding to different classes.
- Manufacturers must establish a quality management system compliant with QSR 820 requirements, and generally need to meet the relevant standards of ISO 13485 for quality management and ISO 14971 for risk management.
- Complete technical documentation must be provided, including product description, design and development documents, performance test reports, biocompatibility reports, sterility validation (for sterile products), etc. High-risk products need to provide clinical trial data to prove safety and effectiveness.
- Products must meet FDA labeling requirements, and manufacturers need to establish a post-market adverse event monitoring system.
Certification Process
- Determine product risk classification and clarify the corresponding market access path.
- Prepare qualified technical documents and quality system documents.
- Complete FDA manufacturer facility and product registration.
- Submit corresponding access applications according to product classification: Class I exempted products can be legally marketed after completing registration; most Class II products need to submit 510(k) Premarket Notification to prove substantial equivalence to a legally marketed predicate device; Class III high-risk products need to submit PMA Premarket Approval applications and provide complete clinical evidence.
- Cooperate with FDA technical review, supplement materials as required, and accept possible on-site audits.
- After obtaining access approval, products can be legally marketed, and manufacturers must maintain ongoing compliance and meet post-market regulatory requirements.
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