US FDA CONSULTANTS

We serve all areas of US FDA related GMP, product approvals, and establishment registrations through our long-standing mastery of technical and regulatory consultation services.

Team I3CGlobal has experience with GMP implementation in a variety of industries, including nutraceuticals, over-the-counter drugs, APIs, and medical devices.

We work with a wide range of loyal clients around the world, ranging from start-ups to large corporations virtually any specialty of the life sciences.

MEDICAL DEVICE REGISTRATION AND DEVICE LISTING

Owners or operators of medical device establishments that are involved in the production and distribution (Exporter & Importer) of medical devices intended for use in the United States are generally required to register with the FDA on an annual basis under title 21 CFR Part 807. Establishment registration is the term for this procedure. In most cases, establishments that are required to register with the FDA must also list the devices they produce and sell.

FDA MEDICAL DEVICE CLASSIFICATION

Medical devices are classified by the FDA into one of three classes based on their risks and the regulatory controls required to provide a reasonable assurance of safety and effectiveness . The three class are  I, II, or III.

Class I devices are the safest for the patient and/or user, while Class III devices are the most risky.

510(k) PREMARKET NOTIFICATION

A 510(k) submission to the FDA demonstrates that the device to be marketed is substantially equivalent (SE) to a legally marketed device in the United States.

You’ll need to apply for PMA if your product is completely new to the market or is classified as a Class III device.

21 CFR 820 IMPLEMENTATION

On June 1, 1997, the 21 CFR 820, generally known as the Quality System Regulations (QSR), went into effect to offer a framework for manufacturers to develop an organizational Quality Management System (QMS).

FDA 21 CFR Part 820, sometimes known as cGMP, defines the criteria for a quality system to comply with FDA rules (current good manufacturing practices). It has several parallels to ISO 13485, particularly when it comes to the quality system standards.

FDA INSPECTION AND 483’s

US Food and Drug Administration (US FDA) inspects and evaluates registered facilities to ensure that they are in compliance with applicable rules and regulations, detailed in code of federal regulations.

A Form 483, commonly known as “Inspectional Observations,” is a list of conditions or procedures that indicate a potential FDA violation. The observations are ranked from most important to least important. This is not an exhaustive list, but rather a snapshot of issues that have been reported on the site.

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