FDA CDRH 2018 Proposed Guidance Development

FDA issued its list of planned Medical Device Guidance development for 2018. This list has 2 parts: priority development referred to as the A-List and other development referred to as B-list.. Note that FDA does not commit to accomplishing all items on either list; it is just stating its current intention. The A-List includes a draft guidance for Validation of Automated Process Equipment Software. FDA also lists which pre-existing guidances they hope to retrospectively review in 2018.

FDA Website (http://goo.gl/yEosLf)

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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