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                Guidance Documents (Medical Devices and Radiation-Emitting Products)

Guidance Documents (Medical Devices and Radiation-Emitting Products)

                        Cross-Center Final Guidance
          Recent Final Medical Device Guidance Documents
          Draft Medical Device Guidance
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          Medical Devices
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          Guidance Documents (Medical Devices and Radiation-Emitting Products)
          Inspection and Field Testing of Radiation-Emitting Electronic ProductsGuidance Documents (Medical Devices and Radiation-Emitting Products) Inspection and Field Testing of Radiation-Emitting Electronic Products
  
  	
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(352 KB)
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**
Objectives
    Program Management Instruction**Part III: Inspectional**
Operations**Part IV: Analytical** (No laboratory testing will be done under this program.)
**Part V: Regulatory / Administrative Follow-Up**
Regulatory Philosophy and Strategy
    District Responsibilities
    Regulatory Action
    Federal / State Relations
    Medical Device Regulatory / Administrative Follow-Up**Part VI: References, Attachments and Program Contacts**
References
    Attachments
    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

                                                                                  Content current as of:
      10/02/2015
              
              
Regulated Product(s)
		 Medical Devices
			  			     			  			     Radiation-Emitting ProductsGuidance Documents (Medical Devices and Radiation-Emitting Products)

          
                        Cross-Center Final Guidance
          Recent Final Medical Device Guidance Documents
          Draft Medical Device Guidance
          CDRH Proposed Guidance Development
          Class II Special Controls Documents
          Withdrawn or Expired Guidance
          Tips for Submitting Comments on CDRH Guidance Documents
 
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