Summary:

On December 16, 2021, the U.S. Food and Drug Administration (FDA) will host a webinar for medical device manufacturers and other interested stakeholders to discuss the draft guidance: Content of Premarket Submissions for Device Software Functions. The draft guidance is intended to reflect FDA's most current thinking on the recommended documentation sponsors should include in premarket submissions for FDA's evaluation of the safety and effectiveness of device software functions, including both software in a medical device (SiMD) and software as a medical device (SaMD). The proposed recommendations are intended to streamline the organization and content of the software documentation and provide helpful prompts and tips to identify the minimum amount of information that, based on FDA's experience, would generally be needed to support a premarket submission for a device that uses software.

The FDA will provide an overview of the draft guidance and respond to questions.

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Background:

This draft guidance, Content of Premarket Submissions for Device Software Functions, was issued on November 4, 2021. It proposes recommendations that apply to all types of premarket submissions that include one or more device software functions.

When final, it will replace the FDA's Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices issued on May 11, 2005.

Stakeholder Call Details:

Registration is not necessary.

Date: December 16, 2021
Time: 1:00 p.m. - 2:00 p.m. ET
Please dial in 15 minutes before the start of the webinar to allow time to connect.

Please click the link below to join the webinar:
https://fda.zoomgov.com/j/1611845469?pwd=YWl2UkdLdHVLNHFkT21kYlpORk1FQT09

Passcode: Ht8*kL

Please note: Participants who join the webinar using the Zoom webinar link above should use computer audio (listen through their computer speakers and speaking through computer microphone/headset).

The dial-in information provided below is for participants who will be joining the webinar by phone only.

• U.S Callers Dial: 833 568 8864
• International Caller Dial: Check international numbers available
• Conference ID Number: 161 184 5469
• Passcode: 468111

Following the webinar, a transcript, recoding, and slides will be posted below.