With expectation of the medical device market in the United States to reach $133 billion by 2016, there is a growing interest for companies to penetrate the largest medical device market in the world with their own technological innovations.
Any company that is involved in the manufacturing, packaging, labeling or importing of medical devices destined to be sold in the United States are over-sighted by the FDA’s Center for Devices and Radiological Health (CDRH). Similar to Canada, the regulatory process varies depending on the classification of the medical device (Class I, II, or III), with regulatory requirements increasing with class rank. In any case, the requirements include establishment registration, listing of devices, manufacturing practices in accordance with the quality system regulation, and reporting of adverse events; with Class II requiring Premarket Notification 510(k) and Class III requiring premarket approval.
NHP Consulting will help evaluate your medical device and determine the proper classification with the FDA. This service also extends to label review in compliance with 21 CFR part 801 and registration of establishment, and includes managing of any regulatory agency inquiries and medical device reporting.