Inhalers, Spacers FDA CDRH 510(k) Nebulizers

“Reviewer Guidance For Nebulizers, Metered Dose Inhalers, Spacers andActuators.”

This document was issued on October 1, 1993. It provides guidance on 510(k) submissions for these devices. It states in section V.C several references related to software including the requirement for detailed discussions of software related device features if there are any. And if there is software in the device then a hazard analysis, software requirements and design information, test plans and protocols with appropriate data and test reports, and documentation of the software development process, inculding the configuration management plan are all required. It also references the now obsolete reviewer guidance for computer controlled medial devices, “Reviewer Guidance for Computer Controlled Medical Devices Undergoing 510(k) Review,” and the current FDA submission guidance, “Guidance for the DContent of Premaket Submissions for Software Contained in Medical Devices,” should be used in its place.

In subsection E it emphasizes that If the device is a modified or enhanced version of a legally marketed device, modifications, if any, in software should be identified and each modifictaion should have some explanitory rational of whether or not the modifications are being implemented to correct problems.

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