Indications for Use Webinar Coming Soon...

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The updated webinar will be hosted live on August 15, 2024, at 10:30 a.m. ET. It will also be recorded. You can purchase it on-demand and watch the training as often as you wish.
In this webinar, we will explain the difference between intended use, indications for use, and intended purpose. You will learn how to create indications for use for a 510(k) and how preparing indications for use is different from a De Novo submission. Finally, we show you how to write a justification for any differences between your device's indications for use and the predicate device in a 510(k) submission.
If you are interested in trying Streamyard for developing your own video content, please check out StreamYard: streamyard.com...

Опубликовано:

16 сен 2024

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Комментарии : 6

@wondetekolla8123 Месяц назад

Good to know that a device can have a different intended patient population and use case than its predicate device and be able to justify it to the FDA.

@MedicalDeviceAcademy 28 дней назад

Yes, this is usually the focus of pre-submission questions that are specific to the topic of "Indications for Use."

@sarooshka25 Месяц назад

Wonderful training as always 👌🏻 Thank you

@MedicalDeviceAcademy 28 дней назад

Glad you enjoyed it! If you have suggestions for future webinars or videos, please let us know in the comments or on our website: medicaldeviceacademy.com/suggestion-portal/

@sarooshka25 28 дней назад

@@MedicalDeviceAcademy more software related content please. How to do design freeze and perform V &V while still using agile and iterative development and testing techniques. What test reports to provide under eStar software section and what reports to provide under eStar performance testing, for SaMD vs SiMD. Thanks.

@MedicalDeviceAcademy Месяц назад

My apologies for not creating a separate slide for "Intended Purpose" as defined for CE Marking. There is an explanation in a MDCG guidance, but the explanation if vague. Therefore, the best way to think of it is: intended purpose = 1) indications for use, 2) intended patient population(s), 3) intended user group(s), and 4) environment of use. All four of these should be in your instructions for use document or user manual.