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

GUIDANCE DOCUMENT

• Docket Number: FDA-2020-D-0957
• Issued by: 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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