510 Research Paper

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The goal of the 510(k) Submission is to demonstrate that the new device is substantially equivalent to one or more named predicate devices. This equivalence must be shown for all aspects of safety and effectiveness. The question of what to test for a device is critical when the test report or results will be used to support a 510(k), submission.
There are three types of Premarket Notification 510(k) s that may be submitted to FDA: Traditional, Special, and Abbreviated. The Special and Abbreviated 510(k) methods were developed under the "New 510(k) Paradigm" to help streamline the 510(k) review process.
All clinical features of the device should be tested, as well as safety, materials biocompatibility, environmental withstand, electromagnetic compatibility, and other areas which are applicable to the device. Most medical devices can be classified by finding the matching description of the device in Title 21 of the Code of Federal Regulations (CFR), Parts 862-892.
What to test?
For Traditional 510(k) submissions, FDA reviewers require performance data from applicants to show “Safety and Effectiveness” to predicate devices. …show more content…
The Food and Drug Administration Modernization Act of 1997 authorized the FDA to recognize standards developed in an open and transparent process, such as those developed by ANSI-accredited standards developing organizations as well as the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC).Recognition of a standard means that FDA will accept testing of a new device against all applicable parts of that standard as an alternative to comparative testing. When a recognized standard is not applicable or when it doesn't cover a particular aspect of a device, testing against the predicate is

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