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

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  • 11 Pages
  • February 2020
  • Region: United States
  • BCC Research
  • ID: 4992374
UP TO OFF until Aug 31st 2033

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


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.

Table of Contents

Chapter 1: Introduction
  • Study Goals and Objectives
  • Scope of Report
  • Information Sources
  • Analyst's Credentials
  • Related 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
Table 1: Class I and Class II Exempt Devices
Table 2: Medical Device User Fee Amendments (MDUFA)-2020
List of Figures
Figure 1: Process for Marketing the Medical Device in the US Market