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

February 2020 | 11 pages | ID: R75EB0182E49EN
BCC Research

Abstracts

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

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)
eCFR
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
Advertising
Medical Device Reporting (MDR)
Local Agent Requirements
Responsibilities of the US agent
Medical Device User Fee

List Of Tables

LIST OF TABLES

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

List Of Figures

LIST OF FIGURES

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