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FDA publishes guidance on device changes:

This article was originally published in Clinica

Executive Summary

The US FDA has published a draft guidance document entitled "Deciding when to submit a 510(k) for a change to an existing device". The document includes a flowchart model which can be used by manufacturers to help decide whether modifications to a device necessitate a new 510(k) submission (see Clinica No 671, p 5). Contact: Division of Small Manufacturers Assistance, CDRH (HFZ-220), FDA, 1350 Piccard Drive, Rockville, MD 20850. Tel: (301) 443 6597. Fax: (301) 443 8818. Comments on the guidance should be sent by December 15th to Dockets Management Branch (HFA-305), FDA, Rm 1-23, 12420 Parklawn Drive, Rockville, MD 20857.

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