FDA Finalizes Peripheral Vascular Atherectomy Guidance
The US agency made few changes in finalizing a 13 February guidance document on medical devices made to remove plaque from diseased arteries, but did incorporate manufacturer recommendations on corrosion testing and predicate comparisons.
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The US agency has finalized an update to a previous guidance on devices used to remove atherosclerotic plaque that addresses new software, pyrogenicity and testing concerns.
US regulators are proposing updates to a guidance document they finalized in February for devices used to clear arteries of plaque. The updated language specifically addresses software interoperability, pyrogenicity and certain performance-testing requirements.
A new final guidance document from the US FDA explains how the agency wants device developers to use its Q-Submission Program to get agency feedback outside the formal product submission process.