Get the free 21 CFR 807.93 -- Content and format of a 510(k) statement.
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000 Mixtec Up, her DEC ier0ssoluti.ons14 2011510(k) Summary of Safety and Effectiveness. This summary of safety and effectiveness is provided as part of this PreMarket Notification in compliance with
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What is 21 cfr 80793?
21 CFR 807.93 is a regulation under the United States Federal Food, Drug, and Cosmetic Act that pertains to the submission of a premarket notification (510(k)) for certain medical devices.
Who is required to file 21 cfr 80793?
Manufacturers of medical devices who intend to market a device in the US that is subject to 510(k) requirements are required to file 21 CFR 807.93.
How to fill out 21 cfr 80793?
To file 21 CFR 807.93, manufacturers must provide detailed information about the medical device, its intended use, and any substantial similarities to legally marketed devices.
What is the purpose of 21 cfr 80793?
The purpose of 21 CFR 807.93 is to ensure that medical devices are safe and effective for their intended use by requiring manufacturers to submit information to the FDA for review before marketing their products.
What information must be reported on 21 cfr 80793?
Information that must be reported on 21 CFR 807.93 includes a description of the device, its intended use, performance data, labeling, and any relevant information about the device's composition, design, materials, and specifications.
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