Are there any considerations when listing standards on a traditional 510(k)? Section I of the cover sheet (Form
FDA 3514) says:
Should all applicable standards, 3rd party tested and self-certified, be included?
What about FCC part 15?
My application also cites ISO 14971, should that be mentioned too?
Thanks
Section 1 of form 3514 asks you for “submission standards or …recognized standards”.
This section should only include all major standards and also standards recognized by the FDA.
Specifically, if you use any CLSI standards you should include them because FDA recognized CLSI.
Also, as an example of major, you should include reference to ISO 13485, ISO 14971, ISO 10993 and ISO 15223. Those are Quality System standards (13485) and specific standards (Biological evaluation for medical devices – ISO 10993; Application of Risk management - ISO14971; Symbols to be used with medical labels – ISO 15223).
In reference to the last example above, I would not include ISO 980 (General symbols labeling standard) because it is not recognized by the FDA and any other referenced self-certified standards.
Please keep in mind, that when you state compliance, make sure it is for the right revision of this standard – good example here would be ISO 14971 (You most likely comply to 2000 revision and not 2007…)
Hope this helps,
Mike