Citation: Sarata AK. FDA Regulation of Medical Devices. Congressional Research Service Report No R47374. 4 January 2023. Available here

ABOUT THE REPORT

This report authored by the US congressional research service for the United State Congress lawmakers describes

• FDA’s authority to regulate medical devices
• Medical device classification panels and regulatory classes
• Device regulatory controls, including general and special controls, as well as premarket approval
• Special programs to improve access to specific devices
• Postmarket surveillance systems

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FDA's AUTHORITY

FDA’s Center for Devices and Radiological Health (CDRH) is primarily responsible for medical device regulation, with assistance from the Center for Biologics Evaluation and Research (CBER).

Medical device manufacturers are subject to a range of regulatory controls (i.e., requirements) to ensure that devices are not adulterated or misbranded and to otherwise assure their safety and effectiveness for their intended use. These requirements include, for example, premarket review, labeling, establishment registration and device listing, and quality system regulation (good manufacturing practices for devices).

CONTENTS OF THE REPORT (TOC)

• Introduction
  
• FDA’s Authority to Regulate Medical Devices
• Medical Device Classification Panels and Regulatory Classes

Classification Panels

> Regulatory Classes / Reclassifications

• Medical Device Regulatory Controls

General Controls

> Establishment Registration / Device Listing

> Premarket Notification (510(k))

> Current Good Manufacturing Practices (Quality System Regulation)

> Adulterated and Misbranded Devices

> Records and Medical Device Reporting

> Banned Devices

> Notification and Recall

> Labeling

Special Controls

Premarket Approval (PMA)

> PMA Amendments and Supplements

> Investigational Device Exemption (IDE)

• Facilitating Access to Medical Devices

Humanitarian Device Exemption

Breakthrough Device Designation

• Postmarket Surveillance

Mandatory Postmarket Studies

> 522 Studies

> Post-Approval Studies

Adverse Event Reporting

National Evaluation System for Health Technology (NEST) and Real-World Evidence (RWE)

• Figures

Figure 1. The 510(k) Third Party Review Program Process

• Tables

Table 1. Medical Device Classification

Table 2. Types of PMA Supplements

• Appendixes

Appendix A. History of Laws Governing Medical Device Regulation

Appendix B. Acronyms Used in This Report

(Total pages: 41)

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