US FDA CONSULTANTS
We, US FDA Consultants and US Agents serve in the areas of FDA related GMP, 510k, product approvals, and establishment registrations through our long-standing mastery of technical and regulatory consulting 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 speciality of the life sciences
MEDICAL DEVICE REGISTRATION AND DEVICE LISTING
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 riskiest. We US FDA Consultants and US Agents support customers.
510(k) PREMARKET NOTIFICATION
A 510(k) filing to the FDA proves that the device being sold is substantially needed to apply for PMA if your product is completely new to the market or is classified as a Class III device. We are FDA Consultants and US Agents support from start to end.
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 quality system standards. We FDA consultants and US Agents support manufacturers with guidance and implementation support.
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 the 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. The role of FDA Consultants is invitable.