Mar 11, 2020   SOURCE: PR NewsWire

U.S. Medical Devices Regulatory Intelligence Report 2020

DUBLIN, March 11, 2020 /PRNewswire/ -- The "Regulatory Intelligence Report for Medical Devices in the U.S." report has been added to ResearchAndMarkets.com's offering.

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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.

The 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 and how it works
        towards the betterment of society

Key Topics Covered

Chapter 1: Introduction

    --  Study Goals and Objectives
    --  Scope of Report
    --  Information Sources

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

For more information about this report visit https://www.researchandmarkets.com/r/y93qbd

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