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

Final

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

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
1002.1No product reportMinorClass B
1002.11No supplemental reportMinorClass B
1002.13No annual reportMinorClass B
1002.2No accidental radiation occurrence reportMinorClass B
Certification requirements
1010.2No certification labelMinorClass B
1010.2Inadequate or lack of testing programMajorClass A
1010.2Incomplete testing---program exists but lacks recordMinorClass B
1010.2Incomplete testing with minor deficienciesConcernClass C
1010.2Reference to DHEW or BRHConcernClass C
1010.3No identification labelConcernClass C
1010.3Coded or abbreviated dateMinorClass B
1010.3Month & year in serial number on non-consumer productConcernClass C
1010.3No manufacturer addressConcernClass C
1010.3Incomplete addressConcernClass C

 


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Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
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All comments should be identified with the title of the guidance.