1.Classification Assessment & Pathway Planning: Determine FDA product classification and optimize registration strategy based on product characteristics.

2.Technical Documentation Preparation: Assist in preparing 510(k)/PMA application documents, clinical evaluation reports, and risk management files.

3.Quality Management System Guidance: Provide QSR 820 compliance consulting, ISO 13485 system implementation, and mock audits.

4.FDA Communication & Agent Services: Designate US Agent and coordinate FDA reviews/inspections.

5.Post-Market Compliance Support: Annual report submissions, adverse event monitoring, and regulatory update tracking.

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1. Definition and Background

U.S. FDA medical device registration refers to the mandatory regulatory process where manufacturers must submit technical documentation, performance data, and compliance information to the U.S. Food and Drug Administration (FDA) to demonstrate product safety and effectiveness before market entry.

The 1976 amendments to the Federal Food, Drug, and Cosmetic Act (FDCA) established the medical device classification system, categorizing devices into Class I, II, or III by risk level. Subsequent regulations like the Safe Medical Devices Act (SMDA) strengthened requirements for adverse event reporting and quality system compliance.

2. Applicable Registration Scope

FDA registration applies to all medical devices sold in the U.S., including:

Product Types:

·Diagnostic devices (e.g., glucose meters, X-ray machines)

·Therapeutic devices (e.g., ventilators, surgical instruments)

·Monitoring devices (e.g., cardiac monitors)

·Laboratory equipment (e.g., biochemical analyzers)

·Rehabilitation devices (e.g., prosthetics)

Risk Classification:

·Class I (Low risk, e.g., surgical gloves, tongue depressors, thermometers): General controls. Typically exempt from 510(k) but require establishment registration and GMP compliance.

·Class II (Moderate risk, e.g., blood pressure monitors, ECG machines, ultrasound diagnostic systems, transfusion/infusion devices, ventilators): Special controls (e.g., specific labeling requirements, mandatory performance standards, post-market surveillance). Most require 510(k) premarket notification.

·Class III (High risk, e.g., artificial heart valves, pacemakers, intraocular lenses, vascular grafts): Require Premarket Approval (PMA) with clinical data.

Applicable Entities: U.S. domestic manufacturers, importers, and foreign manufacturers (must appoint a U.S. Agent).

3. Basic Requirements

·Device Classification: Determine risk class and registration pathway (e.g., 510(k), PMA).

·Technical Documentation: Design files, performance test data, clinical evaluations (if applicable).

·Quality Management System (QMS): Compliance with FDA's QSR 820 (transitioning to QMSR in 2026, aligning with ISO 13485).

·Labeling Compliance: Meets 21 CFR Part 801 (instructions, warnings).

·U.S. Agent Requirement: Foreign manufacturers must designate a U.S. representative.

4. Registration Process

1) Classification: Confirm device class (I/II/III) and application type (e.g., 510(k), PMA).

2)Premarket Submission:

510(k): Substantial equivalence data to a predicate device.

PMA: Full technical documentation + clinical trial data.

3)Establishment Registration & Listing: Submit via FDA’s FURLS system.

4)Fee Payment: Annual fees (small businesses may qualify for reductions).

5)FDA Review & Inspection: Possible GMP audits (especially for Class III).

6)Approval & Post-Market Obligations: Submit annual reports and monitor adverse events.

5. Regulatory Basis

Core Regulations:

·Section 520 of the Federal Food, Drug, and Cosmetic Act (FDCA): Establishes the regulatory framework for medical devices.

·Quality System Regulation (QSR) 820: Governs manufacturing quality systems (to be updated to QMSR in 2026, incorporating ISO 13485 requirements).

·21 CFR Part 801: Specifies labeling and identification requirements.

Special Process Requirements:

·510(k) Premarket Notification (21 CFR 807.87).

·Premarket Approval (PMA) (21 CFR 814.89)