Regulatory Intelligence Report for Medical Devices in the U.S.

Report Includes:

• Detailed description of the regulatory requirements for marketing and registration of medical devices in the U.S.
• Insights into the current regulations and comprehensive procedures for the registration, renewal or notification of the medical devices, along with the information on timeline and fee required
• Knowledge about labelling and advertising regulations for the medical device and details of the process for registration of the product with any specific variation
• Information on Federal Food, Drug, and Cosmetic Act (the Act) and how it works towards the betterment of society

Summary

The goals of this study were to understand the regulations and requirements of the companies in the US and the foreign companies or establishments planning to manufacture, distribute or market their medical devices in the US. This report provides a brief about the related regulation for registration of the establishments or medical devices along with the classification of the devices.