Get the free 21 CFR 807.92 -- Content and format of a 510(k) summary. - eCFR
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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k091555 B. Purpose for Submission: Modifications to a previously cleared device
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How to fill out 21 cfr 80792
How to fill out 21 cfr 80792
01
To fill out 21 CFR 807.92, follow these steps:
02
Begin by providing your company name and address on the top of the form.
03
Fill in the appropriate section for the product owner, including their name, address, and contact information.
04
Indicate the specific type of device being submitted for review and provide its intended use.
05
Detail the manufacturing process and specify the materials used in the device's construction.
06
Provide any necessary clinical data or studies related to the device's safety and effectiveness.
07
Include a detailed description of the device's design, labeling, and any instructions for use.
08
If applicable, provide information on any previous approvals or clearances received from regulatory authorities.
09
Finally, sign and date the form to certify the accuracy and completeness of the submission.
Who needs 21 cfr 80792?
01
21 CFR 807.92 is required by medical device manufacturers who intend to market their products in the United States.
02
It is specifically needed for premarket notification submissions, also known as 510(k) submissions.
03
These submissions are required for certain medical devices that do not need to undergo premarket approval (PMA) by the FDA.
04
Manufacturers must follow the guidelines outlined in 21 CFR 807.92 to meet the regulatory requirements for marketing their devices.
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What is 21 cfr 80792?
21 CFR 807.92 refers to the regulation code for the Medical Device Reporting (MDR) requirements.
Who is required to file 21 cfr 80792?
Manufacturers and importers of medical devices are required to file 21 CFR 807.92.
How to fill out 21 cfr 80792?
To fill out 21 CFR 807.92, manufacturers and importers need to report incidents involving their medical devices that result in serious injury or death.
What is the purpose of 21 cfr 80792?
The purpose of 21 CFR 807.92 is to ensure the safety and effectiveness of medical devices by reporting adverse events.
What information must be reported on 21 cfr 80792?
Information such as the date of the incident, device model, and description of the adverse event must be reported on 21 CFR 807.92.
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