Labeling requirements for X-ray detector

[youuu]

Hello everyone,

I currently work for x-ray detector (not generator) manufacturing company.
I have been having some difficulties regarding labeling requirements.

Please read and .. help me clarify these information.
Is this true? and do I have to include certification statement on my label?

According to - A Guide for the Submission of Initial Reports on Diagnostic X-Ray Systems and Their Major Components - devices under CFR1020.30 have to include certification statement.

102.4
For every model listed under 102.1 and 102.2, provide an exact replica of all labels complete with the following:

a. the certification statement
"This product complies with the applicable DHHS regulations of 21 CFR Subchapter J, applicable at the date of manufacture"

b.the name and address of the manufacturer (or the individual or company under whose name it is sold);

c.the date and place of manufacture; and

d.the model designation and sample serial number;

e.the manufacturer, model designation and sample serial number of the tube insert if applicable.

f.In addition, the standard requires that the labels be permanently affixed, legible, and accessible to view. Provide a drawing or photograph of each certifiable component and/or combination showing the attached label. Attach all of the requested information under this paragraph (102.4) as APPENDIX A.

However, solid state x-ray imaging device (our product) is not listed under 102.1 but is included in CFR1020.30.

I'm having some confusion.. please assure me if I'm going to the right direction.
So my question is do I have to include that certification statement or no?

Thank you very much!

 

[MIREGMGR]

Technology has somewhat surpassed the language of 21CFR 1020.30 and the related sections, in my view. Certainly the radiolucency requirements don't make systemic sense, if they ever did, since they don't address the total stackup of in-beampath devices including supports and patient positioners.

My suggestion would be that you call FDA DSMICA and ask how to directly contact the section that will examine your device, to get a better understanding of whether they want the referenced certification statement.