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U.S. Department of Health and Human Services

Medical Devices

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Inspection of Domestic and Foreign Manufacturers of Diagnostic X-Ray Equipment

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Date of Issuance:

PROGRAM 7386.003a

SUBJECT: INSPECTION OF DOMESTIC AND FOREIGN MANUFACTURERS OF DIAGNOSTIC X-RAY EQUIPMENT

IMPLEMENTATION DATE: 6/1/2008

COMPLETION DATE: 9/14/2011

DATA REPORTING

PRODUCT CODES:
See Attachment A

PROGRAM ASSIGNMENT CODES:
86003

Table of Contents

Cover Page

Part I: Background

Part II: Program / Implementation

  1. Objectives
  2. Program Management Instruction

Part III: Inspectional

  1. Operations

Part IV: Analytical

Part V: Regulatory / Administrative Strategy

  1. Regulatory Philosophy and Strategy
  2. District Responsibilities
  3. Regulatory Action
  4. Federal / State Relations
  5. Medical Device Regulatory / Administrative Follow-Up

Part VI: References, Attachments and Program Contacts

  1. References
  2. Attachments
  3. Program Contacts

Attachments

Attachment A: Diagnostic X-Ray Product Codes

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