The Center for Devices and Radiological Health (CDRH) is the branch of the US Food and Drug Administration(FDA) responsible for the premarket approval of all medical devices, as well as overseeing the manufacturing, performance and safety of these devices. Manufacturers importing medical devices into the USA must designate a United States agent.

Medical devices are classified into Class I, II, and III. Regulatory control increases from Class I to Class III. Most Class I devices are exempt from Premarket Notification, the 510(k), while most Class II devices require Premarket Notification 510(k). And most Class III devices require Premarket Approval (PMA). All manufacturers must register the establishment and list their device and comply with the quality system requirements. Also, a post marketing surveillance system is required (21 CFR Part 803).

The traditional CDRH approach for review and clearance of medical devices is going through drastic changes.  The CDRH is trying to help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices. More stringent requirements and further control of the traditional practice of the 510K processes is expected.  Our country specific (*) regulatory services in the USA include:

Medical Device specific regulation strategy reports, Manufacturer registration and Medical Device listing, Designated regulatory agent in the USA for non USA manufacturers, FDA Technical documents preparation including 510(K), Denovo and PMA submissions, Pre-IDE and other strategic discussions with the FDA, cGMP quality system establishment and implementation,  inspection and auditing, Clinical research planning management and administration services and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™

Please fill the following form and submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in the United States of America!

(*) USA Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat service.