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U.S. Department of Health and Human Services

Medical Devices

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Medical Device Premarket Approval and Postmarket Inspections

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PROGRAM 7383.001

Subject: Medical Device Premarket Approval and Postmarket Inspections

IMPLEMENTATION DATE: 03/05/2012

COMPLETION DATE: 03/05/2012

PRODUCT CODES:
73–91

PROGRAM ASSIGNMENT CODES:
83001 Premarket Approval Inspections
83001A Postmarket Inspections


Table of Contents

Cover Page and Index

Field Reporting Requirements

  1. PMA Preapproval Inspections — PAC Code 83001
  2. PMA Postmarket Inspections — PAC Code 83001A

Part I: Background

  1. Premarket Approval and the Quality System Regulations
  2. The Medical Device Reporting Regulation
  3. The Medical Device Tracking Regulation
  4. The Corrections and Removal Regulation
  5. The Registration and Listing Regulation

Part II: Implementation

  1. Objectives
  2. Program Management Instructions

Part III: Inspectional

  1. Operations
  2. Special Situations
  3. Reporting

Part IV: Analytical
Refer to Part IV of CP 7382.845, "Inspection of Medical Device Manufacturers," for a listing of the designated testing facilities and methodology for sample collection and analysis.

Part V: Regulatory / Administrative Follow-Up

  1. PMA Preapproval Inspections
  2. PMA Postmarket Inspections

Part VI: References, Attachments and Program Contacts

  1. Applicable References
  2. Program Contacts
  3. Attachments

Attachments

Attachment A: Notification of PMA Postmarket Inspection Form

Attachment B: CDRH Office of Compliance Organizational Chart

Attachment C: CDRH Office of In Vitro Diagonostic Devices Organizational Chart