Webinar – Ultimate Guidance_ Content material of Premarket Submissions for System Software program Features – 07_20_2023

Date: July 20, 2023 Time: 1:00 PM – 2:00 PM ET


On July 20, 2023, the U.S. Meals and Drug Administration (FDA) will host a webinar for business and different stakeholders to debate the ultimate steering: Content material of Premarket Submissions for System Software program Features.

Throughout this webinar, the FDA will:

Focus on the risk-based method to figuring out the advisable documentation degree for a premarket submission

Focus on the suggestions for data to be included in premarket submissions for Fundamental and Enhanced Documentation Ranges.

Reply questions in regards to the closing steering.

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The aim of this steering is to explain the FDA’s pondering on the advisable documentation sponsors ought to embody in premarket submissions for the FDA’s analysis of the protection and effectiveness of system software program features. This steering replaces the FDA’s Steerage for the Content material of Premarket Submissions for Software program Contained in Medical Gadgets issued on Might 11, 2005 and describes data that may be usually generated and documented throughout software program growth, verification, and validation. This pondering acknowledges modifications to the FD&C Act made by the twenty first Century Cures Act (Cures Act), which amended part 520 of the FD&C Act and excludes sure software program features from the system definition. It additionally considers the quickly evolving nature of digital well being and up to date FDA-recognized consensus requirements associated to software program.

Webinar Particulars

Registration isn’t crucial.

Date: July 20, 2023

Time: 1:00 PM – 2:00 PM ET

Please dial in quarter-hour earlier than the beginning of the decision to permit time to attach.

Please click on the hyperlink beneath to affix the webinar: https://fda.zoomgov.com/j/1618744961?pwd=MmdVdEd1YnVscHF2K01TWlp6QU45QT09

Passcode: HHq6&G

Please word: Members who be part of the webinar utilizing the Zoom webinar hyperlink above ought to use laptop audio (hear via their laptop audio system and talking via laptop microphone/headset).

The dial-in data offered beneath is for individuals who might be becoming a member of the webinar by telephone solely.

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Webinar Supplies

The presentation, printable slides, and transcript might be out there at CDRH Study underneath “Specialty Technical Matters”, sub-section “Digital Well being.”

When you’ve got questions on this steering doc, please contact the CDRH Digital Well being Middle of Excellence at digitalhealth@fda.hhs.gov. When you’ve got questions on this webinar, please contact CDRH’s Division of Trade and Client Training (DICE) at cube@fda.hhs.gov, 1-800-638-2041, or 301-796-7100.