FDA manual offers help on 510(k) submissions:
This article was originally published in Clinica
Deciding when to submit a 510(k) for a change to an existing device is the title of a new manual available from Biomedical Market Newsletter. The manual covers all medical devices, equipment and instruments and can be used to advise manufacturers on, among other topics, GMPs, models and labelling changes and IVD products. Copies are available at $45 ($49 after July 1st) from BMN tel: +1 714 434 9500, fax: +1 714 434 9755.
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