Get the free FORM FDA 3645. Guide for Preparing Annual Reports forUltrasonic Therapy Products
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Form Approved: OMB No. 09100025 Expiration Date: August 31, 2023FORM FDA 3645 (09/20) Guide for Preparing Annual Reports for Ultrasonic Therapy ProductsPublic reporting burden for this collection
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What is form fda 3645 guide?
Form FDA 3645 guide is a document provided by the Food and Drug Administration (FDA) to guide manufacturers on how to report adverse events related to medical devices.
Who is required to file form fda 3645 guide?
Manufacturers of medical devices are required to file form FDA 3645 guide.
How to fill out form fda 3645 guide?
Form FDA 3645 guide can be filled out electronically on the FDA's website or submitted via mail.
What is the purpose of form fda 3645 guide?
The purpose of form FDA 3645 guide is to ensure that manufacturers report any adverse events related to their medical devices to the FDA in a timely manner.
What information must be reported on form fda 3645 guide?
Information such as the type of adverse event, patient information, device details, and any actions taken in response to the event must be reported on form FDA 3645 guide.
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