FDA certification system
Overview
It is a national health institution that protects US consumers while operating the FD&C Act and related national health laws. It determines whether food, cosmetics, drugs, and medical devices consumed by consumers are safe and effective. Of these, medical devices have a strict management system due to the characteristics that they are applied directly to the human body, and in some cases, not only finished products but also accessories and components are treated as medical devices. Therefore, understanding the FDA registration system is the first step of export to the US.
FDA approval procedure for medical devices
Medical device factory registration and product registration: All manufacturers and importers must register factory and designate a representative in the US. Factory registration must be renewed annually (21 CFR Part 807).
Premarket Notification (510(k))
If the device has the same technical characteristics, safety and efficiency with a legally marketed device, the applicant submit the related documents
Premarket Approval (PMA)
It is the most stringent marketing application required by the FDA. In the PMA application form, sufficient documents on the safety and efficacy of the device should be included. The PMA audit consists of administrative/application audit, scientific and regulatory audit, advisory committee audit/recommendation, and documented notification of final approval.
KTR service
We provide reliable service through cooperation with US local laboratories and US agents registered in FDA.
(Required documents, test progress, technical document review, English grammar review, supplementary document guide, FDA local official Correspondent role)
Point of contact
| Name | Position | Task | Tel | |
|---|---|---|---|---|
| Park Jinjae | Manager | KC, CB, CCC, CE etc Global Certificate | +82-2-2164-1479 | jjpark@ktr.or.kr |
