Sample product pages from Guide to Medical Device Regulation

Sample product pages from Guide to Medical Device Regulation

Public �100 Executive Summary

Public �120 The Path to the Marketplace

Public �1310 Scope and Implementation of Preemption

Public �1330 Personal Injury Claims

Public �230 FDA’s Application of the Device Definition

Public �320 Establishment Registration and Device Listing Regulations

Public �530 IDE Regulations

Public �540 Significant Risk Devices

Public �560 Responsibilities of Sponsors, Investigators, and IRBs

Public �600 Executive Summary

Public �610 Quality System Regulation Scope

Public �620 Quality Systems Requirements

Public �630 Design Controls

Public �650 Purchasing, Acceptance and Servicing Activities

Public �660 Production and Process Controls

Public �670 Quality System Manufacturing Controls

Public �680 Record Keeping

Public �690 Compliance Implications

Public �700 Executive Summary

Public �710 Premarket Approval Applications

Public �730 FDA's Action on a PMA Application

Public �760 Confidentiality

Public �780 Humanitarian Devices

Public �800 Executive Summary

Public �810 Purpose of Premarket Notification

Public �830 Who Must File a Premarket Notification

Public �840 Exemptions From Filing 510(k)s

Public �850 Content of Premarket Notification Submission

Public �860 The 510(k) Decision-making Process

Public �900 Executive Summary

Public �910 Overview of MDR Requirements

Public �920 Manufacturer and Importer Reporting Requirements

Public �950 Postmarket Surveillance