Hello everyone, my name is Matthew Walker with Medical Device Academy and this is another episode of our narrated blog series. Today’s blog title is “513g Request for Information” written by Robert Packard and published on April 9th, 2024.
Version 1.0 of the FDA PreSTAR template, released March 29th, now enables the use of the PreSTAR template for 513g requests for information.
This narrated blog will answer questions such as:
- What is a 513g request?
- Is it required to use the new FDA PreStar v1.0 template for a 513g request?
- What is the required content of a 513g request?
- When should a 513g request be submitted?
- How to prepare a 513g request?
- What other resources are available?
plus information on our 513g training webinar and templates.
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Негізгі бет 513g Request for Information narrated blog from Medical Device Academy
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