Devices

Guide Updated on Device Development Tools

FDA has made minor changes to its final guidance entitled “Qualification of Medical Device Development Tools (MDDTs).” The document describes the agency’s voluntary program for qualifying MDDTs for use in evaluating devices regulated by CDRH.

The Center says the following minor procedural updates and clarifications were made to the guidance:

A simplified framework is described for submitting a voluntary proposal and qualification package for an MDDT. This is intended to streamline the MDDT review process by providing feedback in the proposal phase and removing the optional pre-qualification and incubator phases.
Definitions are clarified for applicable terms and criteria used in evaluating an MDDT for a specific context of use. It also discusses considerations for qualification, and the contents of a qualification package.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome