International Regulatory Affair Services
Isah Health

United States of America

Food & Drug Administration

Establishments that are involved in the production and distribution of medical devices intended for commercial distribution in the United States (U.S.) are required to register annually with the FDA. Most establishments that are required to register are also required to list the devices and the activities performed on those devices at that establishment.

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification also called PMN or 510(k). This allows FDA to determine whether the device is equivalent to a device already placed into one of the three classification categories.Medical device manufacturers are required to submit a premarket notification if they intend to introduce a device into commercial distribution for the first time or reintroduce a device that will be significantly changed or modified to the extent that its safety or effectiveness could be affected. Such change or modification could relate to the design, material, chemical composition, energy source, manufacturing process, or intended use.

The approval processes for medical devices and drugs applications includes a review of the manufacturer’s compliance with the CGMP. FDA inspector determine whether the firm has the necessary facilities, equipment and skills to manufacture the device.

Our staff can be chosen as Representation Agents for US FDA to get GMP Certification.

Manufacturers must establish and follow quality systems to help ensure that their products consistently meet applicable requirements and specifications. The quality systems for FDA-regulated products (food, drugs, biologics, and devices) are known as current good manufacturing practices (CGMP’s). CGMP requirements for devices in part 820 (21 CFR part 820) were first authorized by section 520(f) of the Federal Food, Drug, and Cosmetic Act (the act). Under section 520(f) of the act, FDA issued a final rule in the Federal Register of July 21, 1978 (43 FR 31 508), prescribing CGMP requirements for medical devices.

The QS regulation applies to finished device manufacturers who intend to commercially distribute medical devices. A finished device is defined in 21 CFR 820.3(l) as any device or accessory to any device that is suitable for use or capable of functioning, whether or not it is packaged, labeled, or sterilized.

We offer Quality System training courses for the Medical Device industry to get ready for GMP official inspections in U.S.

Ask for customized programs.

This process is a written request for information respecting the class in which a device has been classified or the requirements applicable to a device under the Act.

513(g) “Typical” Inquiries

  • Determine whether a product is subject to FDA regulations.
  • Determine whether a device is exempt from the 510(k) requirements of the Act.
  • Determine whether a 510(k) is needed for a modification to one's device.
  • Determine the least burdensome regulatory pathway for a device, which introduces a new technology or a new intended use.