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GUIDANCE DOCUMENT

Inspection and Field Testing of Radiation-Emitting Electronic Products: Attachment A October 2007

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health, Office of Product Evaluation and Quality, Office of In Vitro Diagnostics and Radiological Health

The following items are common to all EPRC inspections and field tests, and may be cited for any product subject to the below reporting or certification requirements. Products subject to reporting are listed in Table 1 of 1002.1, and certification requirements are applicable to all products subject to a performance standard.

Reporting requirements
1002.1 No product report Minor Class B
1002.11 No supplemental report Minor Class B
1002.13 No annual report Minor Class B
1002.2 No accidental radiation occurrence report Minor Class B
Certification requirements
1010.2 No certification label Minor Class B
1010.2 Inadequate or lack of testing program Major Class A
1010.2 Incomplete testing---program exists but lacks record Minor Class B
1010.2 Incomplete testing with minor deficiencies Concern Class C
1010.2 Reference to DHEW or BRH Concern Class C
1010.3 No identification label Concern Class C
1010.3 Coded or abbreviated date Minor Class B
1010.3 Month & year in serial number on non-consumer product Concern Class C
1010.3 No manufacturer address Concern Class C
1010.3 Incomplete address Concern Class C

 


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