FDA Medical Device Certification

The United States represents the world's largest consumer market. For medical device products to enter the U.S. market, they must first obtain FDA certification.

I. U.S. Regulatory Authorities

1. U.S. FDA (Food and Drug Administration)

CDRH (Center for Devices and Radiological Health): Responsible for the review and approval of medical devices entering the market. It handles submissions such as Premarket Notifications (510(k)), Premarket Approval (PMA) applications, as well as devices that are not yet approved but intended for use in clinical trials.

CBER (Center for Biologics Evaluation and Research): Oversees the regulation of medical devices related to biological products.

2. Regulatory Framework

- 1976: Food, Drug, and Cosmetic Act (FDCA), Medical Device Amendments

- 1990: Safe Medical Device Act (SMDA)

3. Medical Device Classification and Registration Pathways

II. Registration Process | Timeline

Registration Process

2. Registration Timeline

510(k)/PMA Approval Timeline

III. Our Services

1. Regulatory Strategy and Product Classification

Product Classification and Pathway Determination: Accurately determine your product's FDA classification (Class I, II, or III) and recommend the optimal premarket submission pathway (e.g., 510(k), De Novo, PMA), avoiding strategic misdirection.

Regulatory Roadmap Development: Develop a tailored, end-to-end regulatory strategy and timeline spanning from design and development through to final approval.

2. 510(k) Submission Services

Predicate Device Identification: Precisely identify and scientifically justify the most appropriate predicate device(s) based on regulatory and technical rationale.

Substantial Equivalence Demonstration: Conduct a systematic comparative assessment and author a compelling demonstration of substantial equivalence report.

Full 510(k) Document Preparation and Compilation: Professionally compile the submission dossier, including the 510(k) Summary, device description, testing reports (performance, biocompatibility, sterilization, electrical safety, software validation, etc.), and labeling, ensuring a comprehensive and compliant submission package.

3. De Novo and PMA Submission Services

Clinical Trial and Technical Support: Provide comprehensive support for De Novo and PMA applications, including Investigational Device Exemption (IDE) application, design and management of clinical trials process, clinical trial data management and statistical analysis, and preparation of technical documentation.

FDA Meeting Support: Assist in preparing for key FDA meetings such as Pre-Submissions, distill core issues, prepare meeting materials, and maximize communication effectiveness.

4. Quality Management System (QMS) Establishment and Review

QSR 820 Compliance: Assist in establishing, implementing, and maintaining a QMS fully compliant with FDA Quality System Regulation (21 CFR Part 820).

Mock FDA Audit: Provide simulated audit services to identify system gaps, implement corrective actions in advance, and ensure preparedness for FDA on-site inspections.

Gap Analysis and System Optimization: Conduct gap analysis of existing systems and provide targeted optimization solutions.

5. Product Listing

Establishment Registration and Product Listing: Assist in completing FDA establishment registration and product listing.

6. Post-Market Surveillance and Compliance

Adverse Event Reporting: Guide the establishment of a system compliant with Medical Device Reporting (MDR) requirements, ensuring timely and compliant reporting of adverse events.

Post-Market Surveillance Plan: Assist in developing and executing post-market surveillance plans, continuously collecting real-world data to fulfill FDA requirements for post-market safety monitoring.

7. US Authorized Representative

US Authorized Representative: Provide authorized representative services that meet regulatory requirements and possess full compliance capabilities.

IV. Certificate Template

510K