FDA Medical Device 510(k)

FDA (Food and Drug Administration)

Medical devices require more certification, advance preparation, and consulting as they get higher grades. Accordingly, ICMC (International Certification Management Center Co., Ltd.) is providing differentiated FDA registration and certification consulting along with local agent agencies regarding essential requirements for domestic medical device manufacturers to advance into the U.S.A.

The Food and Drug Administration (FDA) is an institution such as the Ministry of Food and Drug Safety (MFDS), Japan's MHLW, and China's SFDA, which operates the FD&C Act and several related national health laws and protects U.S. consumers.

FDA's investigations, analysis, research, and compliance monitoring are overseen by the National Center for Medical Device and Radiation Protection, Center for Biology and Research, Center for Drug Evaluation and Research, Center for Food Safety and Nutrition, and Center for Veterinary Medicine. In addition, it plays a role in protecting public health by managing the safety, efficient production, distribution, and sales of products used by consumers.

Establishment Registration required by FDA

It is a regulatory procedure similar to Korea's "business license," and in order to distribute medical devices for sale or lease in the United States, manufacturers and importers must register facilities related to the production and distribution of medical devices with the FDA according to the [21CFR 807 Subpart B/C] procedure.

• Information required for manufacturer registration: manufacturer's business name, address, contact information / US agent's business name, address, contact information / US importer's business name, address, and contact information
• After completing the manufacturer registration, before registering the product, the importer who wants to import the product must also be separately registered through Initial importer Registration.

FDA Establishment Registration target

• Manufacturer(both domestic and foreign)
• Re-packer & Re-labeller

FDA Establishment Registration checklist

• Medical device manufacturer establishment registration does not mean approval of establishment and products, so even if establishment registration is completed, approval for establishment and products must be carried out separately.
• Plants and establishment are not required to be registered prior to proceeding with a 510(k) or PMA, but must be registered at least 30 days prior to device sale.

FDA Class II(510(k)) Device Registration target

Submission of Class II devices must go through the ‘Pre-market Notification’ procedure called ‘Pre-market notification’ and is usually called 510(k).
Class II products have the same purpose and performance when comparing the Substantial Equivalence (SE) of the new product to be declared with the existing predicate device. The 510(k) product review process is applicable for identified products. After obtaining permission, it is subject to GMP, and GMP is randomly selected every 2-3 years after approval.

※ A 510(k) permit is essential for companies wishing to export to the United States, and the equivalence (SE) of a similar product that has already been approved by the FDA is an important factor in determining the 510(k) permit.

FDA Class II(510(k)) Review Type

FDA Establishment Registration Checklist

• Search and check Class, Product Code, SE(Substantial equivalence)
• Establishment Registration agency
• Product Registration Agency
• Product label consulting
• US Agent acting
• Annual Registration Service

FDA Class II(510(k)) Device Registration target

• Class II(510(k)) Medical Device Manufacturer(both domestic and foreign)
• Class II(510(k)) Medical Device Re-packer & Re-labeller

FDA Class II(510(k)) Device Registration process

Related major websites