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US FDA Registration

The Food and Drug Administration (FDA), an international medical evaluation authority, was empowered by the United States Congress (the federal government) to serve as the highest law enforcement agency engaged in the regulation of food, drugs, medical devices, electromagnetic radiation emitting devices (ERED), vaccines, blood and biological products, animal food & feeds and veterinary products, cosmetics and tobacco products.

FDA regulates medical devices through the Center for Devices and Radiological Health (CDRH), which supervises medical device manufacturers, packers and distributors to conduct business activities under the premise of abiding by laws. Medical devices, ranging in nature and complexity from simple medical gloves to complex pacemakers, are all under FDA supervision. FDA divides medical devices into classes I, II and III, taking into account the intended purpose of the devices and their inherent risks (the higher the classification, the stricter the regulation).

A Quality System that complies with 21 CFR Part 820 and other relevant regulations is necessary. Given that the latest iteration of ISO 13485:2016 is more closely aligned with the Quality System Regulations (QSR) compared to previous versions, the FDA intends to synchronize the QSR with international standards. Additionally, the United States is involved in the MDSAP Program (Medical Device Single Audit Program) alongside Brazil, Canada, Australia, and Japan.

To market medical devices in the United States, they must be registered with the FDA. Manufacturing facilities undergo FDA inspections to ensure compliance with American Good Manufacturing Practice (GMP) standards. Additionally, establishments involved in device production, distribution, import, and marketing in the USA must be disclosed and registered with the FDA through Establishment Registration, as per 21 CFR 807.

Class I Medical Devices: While some Class I devices are exempt from most Quality System Regulation (QSR) requirements, a Quality Management System (QMS) partially conforming to 21 CFR 820 must be implemented. Even exempt devices must comply with 21 CFR 820.180 (Record Keeping) and 21 CFR 820.198 (Complaints File). Once Establishment Registration fees are paid, manufacturers can complete online device listing for Class I devices.

Class II Medical Devices: These require a QMS compliant with 21 CFR 820. Innovative devices may need clinical studies, necessitating early FDA feedback via a Pre-Submission (Pre-Sub) request. For devices requiring clinical trials, an Investigational Device Exemption (IDE) application is needed to collect safety and efficacy data. For Class II devices not needing clinical studies, a 510(k) Premarket Notification and fee payment are required for FDA clearance.

Class III Medical Devices: A 21 CFR 820-compliant QMS is necessary. Marketing approval requires submitting a Premarket Approval (PMA) application with a fee. FDA assesses if the PMA provides valid scientific evidence of device safety and efficacy. FDA inspects all operators involved in device design and production to ensure QMS compliance. Upon successful PMA application, FDA approves marketing. Manufacturers must annually register their establishment, perform device listing, and comply with American GMPs after FDA approval.

Applicant: The manufacturer appoints a U.S. Agent for communication with the FDA, especially for foreign manufacturers intending to market in the U.S.

Timeframe and Fees: Approval times vary by device class: Class I (1 month), Class II (4-8 months), Class III (18-30 months). FDA publishes updated fees annually based on the Medical Device User Fees for Fiscal Year.

Validity: Device registration is indefinite unless substantial changes occur. Establishment Registration and Device Listing require annual renewal.

Labelling and Documentation Language: English documentation and labeling complying with 21 CFR 801, approved during device registration, are necessary.

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