Scribd Logo
Upload

Welcome to Scribd!

  • FDA Med. Device Regulations

    Uploaded by

    sapis18
    3 views1 page
    This document provides an overview of FDA regulations for medical devices. It discusses how devices are classified into different risk categories and the approval processes required for each class. It also summarizes the key components and pathways for 510(k) premarket notifications, which demonstrate that new devices are substantially equivalent to existing devices. The document serves as an introduction to important FDA concepts and requirements for bringing medical devices to market.

    Original Description:

    FDA med. device regulations

    Copyright

    © © All Rights Reserved

    Available Formats

    PDF, TXT or read online from Scribd

    Did you find this document useful?

    Is this content inappropriate?

    Report this Document
    This document provides an overview of FDA regulations for medical devices. It discusses how devices are classified into different risk categories and the approval processes required for each class. It also summarizes the key components and pathways for 510(k) premarket notifications, which demonstrate that new devices are substantially equivalent to existing devices. The document serves as an introduction to important FDA concepts and requirements for bringing medical devices to market.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    3 views1 page

    FDA Med. Device Regulations

    Uploaded by

    sapis18
    This document provides an overview of FDA regulations for medical devices. It discusses how devices are classified into different risk categories and the approval processes required for each class. It also summarizes the key components and pathways for 510(k) premarket notifications, which demonstrate that new devices are substantially equivalent to existing devices. The document serves as an introduction to important FDA concepts and requirements for bringing medical devices to market.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Flag for inappropriate content
    of 1

    5

    FDA Medical Device


    Regulation
    Barry Sall

    CONTENTS
    Introduction ....................................................................................................... 126
    Is It a Device? ................................................................................................... 128
    Product Jurisdiction...................................................................................... 128
    Types of Medical Devices ............................................................................ 129
    Medical Device Classification .......................................................................... 129
    Determining Device Classification............................................................... 130
    Reclassification ............................................................................................ 132
    An Introduction to the MedicalDevice Approval Process................................ 135
    Strategic Choices .......................................................................................... 135
    Modification of Marketed Devices ............................................................... 136
    Design Controls ................................................................................................ 137
    The Difference between Research and Development .................................. 137
    Design Control Components ........................................................................ 138
    Medical Device Clinical Research .....................................................................141
    Exempted Studies ......................................................................................... 142
    Nonsignificant Risk Studies ......................................................................... 142
    Significant Risk Studies ............................................................................... 144
    The Investigational Device Exemption ........................................................ 144
    Unique Aspects of Medical Device Studies ................................................. 144
    The 510(k) Premarket Notification ................................................................... 146
    Substantial Equivalence ................................................................................147
    Types of 510(k)s ........................................................................................... 148
    Traditional 510(k).................................................................................... 148
    Abbreviated 510(k).................................................................................. 148
    Special 510(k).......................................................................................... 150
    De Novo 510(k) ....................................................................................... 150
    510(k) Components ...................................................................................... 150
    The Cover Sheet (Form FDA 3514) ........................................................ 150
    The Cover Letter...................................................................................... 150
    The Table of Contents ............................................................................. 151
    User Fee Information............................................................................... 151
    Form FDA 3654 ...................................................................................... 151
    Statement of Substantial Equivalence ..................................................... 151
    125

    You might also like