Medical Device Product Registration and Approval
MEDICAL DEVICE REGULATION IN UNITED STATES (US)
Medical Devices are regulated by Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration in the US. Medical Devices are regulated under Federal Food Drug & Cosmetic (FD&C) Act.
The regulations implementing FD&C Act are Title 21 Code of Federal Regulations (21CFR) Parts 800 – 1299.
MEDICAL DEVICE REGISTRATION AND APPROVAL IN US
Medical devices are classified into 3 regulatory classes, the following are the Device Classes and their Regulatory Controls
1. Class I General Controls
2. Class II General Controls and Special Controls
3. Class III General Controls and Premarket Approval
Class I being the lowest class which signifies a lowest risk device while Class III being the highest class signifies a highest risk device.
The class assigned determines the type of premarketing submission/application required for FDA clearance to market. The most common types of premarket submissions include:
510(k) (Premarket Notification)
PMA (Premarket Approval)
De Novo (Evaluation of Automatic Class III Designation)
HDE (Humanitarian Device Exemption)
IDE (Investigational Device Exemption)
Besides premarketing submission/application, manufacturer has to ensure that the established quality system meets Quality System Regulation (21 CFR 820).
In addition, foreign manufacturers must appoint an US agent as a local point of contact with FDA.
LATIN AMERICA REP
Foreign manufacturers must appoint an US agent as a local point of contact with US FDA.
If you are a foreign manufacturer, you may appoint ARQon to act as your authorized representative in the US.
Some of the responsibilities include:
Acting as a first point of contact with Regulatory authorities and import/customs offices
Being responsible for pre-certification and post-approval inquiries
Liaising between the Medical Device authority and foreign manufacturer in incident of Field Safety Corrective Action (FSCA), serious adverse event reporting to competent authorities, and in cooperation with manufacturer’s distributor