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U.S. Department of Health and Human Services

Medical Devices

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Inspection of Medical Device Manufacturers

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Document issued on: February 2, 2011

PROGRAM 7382.845

SUBJECT: INSPECTION OF MEDICAL DEVICE MANUFACTURERS

IMPLEMENTATION DATE: February 02, 2011 (Previous editions obsolete.)

COMPLETION DATE: February 2, 2015

DATA REPORTING

PRODUCT CODES: 73-91

PRODUCT/ASSIGNMENT CODES:

82845A; 42845A -- All Level 1 (Abbreviated) Inspections
82845B; 42845B -- All Level 2 (Comprehensive) Inspections
82845C; 42845C -- All Level 3 (Compliance Follow-up) Inspections
82845G -- All For Cause Inspections
82845P -- Joint FDA/Accredited Person Inspections
82845S -- Report Time spent on Assessment of Firm’s Sterilization processes
81010 -- Report Time spent on MDR Follow-up
81011 -- Report Time spent on Assessment of Firm’s MDR Practices
81845T -- Report Time spent on Assessment of Firm’s Tracking Practices
81845R -- Report Time spent on Assessment of Firm’s Corrections and Removals Practices
82A800 -- Independent Accredited Person Inspections


Table of Contents

Cover Page: Field Reporting Requirements

Part I: Background

  1. The Quality System (QS) Regulation
  2. The MDR Regulation
  3. The Medical Device Tracking Regulation
  4. The Corrections and Removals Regulation
  5. The Registration and Listing Regulation

Part II: Implementation

  1. Objectives
  2. Program Management Instructions

Part III: Inspectional

  1. Operations
    1. Inspectional Strategy
      1. QS inspections
      2. Level 1 inspections
      3. Level 2 inspections
      4. Level 3 inspections
      5. For Cause Inspections
      6. Foreign Inspections
    2. Inspectional Instructions
    3. Special Instructions Concerning Design Controls
    4. Special Instructions for Sterilization Processes
    5. Inspection of Radiation Emitting Devices
    6. Sample Collection
  2. Additional Considerations
    1. Registration and Listing
    2. Imports
    3. Exports
    4. Electronic Records and Electronic Signatures
  3. Remarketed Devices
  4. Reporting

Part IV: Analytical

  1. Analyzing Laboratories
  2. Analyses to be Conducted
  3. Methodology

Part V: Regulatory/Administrative Follow-up 

  1. Quality System/GMP Regulatory/Administrative Follow-up
    1. Compliance Decision
    2. Contract Sterilizers, Contract Device Manufacturers and Finished Device Manufacturers – Deciding Responsibility When Taking Regulatory Action
    3. Violative Devices Sold to Government Agencies
    4. Administrative and Judicial Actions
    5. Facilitating Review of Regulatory Recommendations
  2. MDR Regulatory/Administrative Follow-up
  3. Tracking Regulatory/Administrative Follow-up
  4. Corrections and Removals Regulatory/Administrative Follow-up
  5. Registration and Listing Regulatory/Administrative Follow-up
  6. Radiation Emitting Device Regulatory/Administrative Follow-up
  7. Exports Regulatory/Administrative Follow-up

Part VI: References and Program Contacts 

Attachments

Attachment A: CDRH Office of Compliance Organizational Chart

Attachment B: CDRH Office of In Vitro Diagnostic Devices Organizational Chart

Attachment C: Summary of MDR Reporting Requirements

Attachment D: Summary of Tracking Requirements

Attachment E: Field Reporting Requirements