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U.S. Department of Health and Human Services

Medical Devices

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Inspection and Field Testing of Radiation-Emitting Electronic Products

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PROGRAM 7386.001

Subject: Inspection and Field Testing of Radiation-Emitting Electronic Products

IMPLEMENTATION DATE: 10/31/2007

COMPLETION DATE: 09/13/2011

DATA REPORTING

PRODUCT CODES:
95RH-XXX (See Attachment B for detail)
95RH-XXX (See Attachment C for detail)
94RH-XXX (See Attachment D for detail)

PROGRAM ASSIGNMENT CODES:
86001
86002
86004


Table of Contents

Cover Page: Field Reporting Requirements

Part I: Background

Part II: Program / Implementation

  1. Objectives
  2. Program Management Instruction

Part III: Inspectional

  1. Operations

Part IV: Analytical (No laboratory testing will be done under this program.)

Part V: Regulatory / Administrative Follow-Up

  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: Classification Table for Reporting and Quality Control Testing Program Non-Compliant Items

Attachment B: Specific Instructions for Laser Product Inspections and Tests

Attachment C: Specific Instructions for Sunlamp Product Inspections and Tests

Attachment D: Specific Instructions for Cabinet X-Ray Product Inspections and Tests

Attachment E: Specific Instructions for Television Product Inspections

Attachment F: Instructions for Microwave Oven Product Inspections