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

Published By :

BCC Research

Published Date : Feb 2020

Category :

Medical Equipments

No. of Pages : 11 Pages


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."

"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"
Table of Contents
Chapter 1 Introduction
Study Goals and Objectives
Scope of Report
Information Sources
Analyst's Credentials
Related BCC Research Reports
Chapter 2 Governing Authority and Classification
Governing Regulatory Authority
Medical Device Definition and Classification
Chapter 3 Regulations
Code of Federal Regulations (CFR)
Premarket Notification 510(k) Clearance to Market
510 (k) Exempt Devices
PMA (Pre-Market Approval)
Good Manufacturing Compliance (GMP) Compliance
Establishment Registration
Device Registration and Listing
Labelling Requirement
Medical Device Reporting (MDR)
Local Agent Requirements
Responsibilities of the US agent
Medical Device User Fee

List of Table

List of Tables
Table 1 : Class I and Class II Exempt Devices
Table 2 : Medical Device User Fee Amendments (MDUFA)-2020

List of Chart

List of Figures
Figure 1 : Process for Marketing the Medical Device in the US Market

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