Whenever a new drug or medical device is developed for general use, it has to go through a rigorous testing and approval procedure before it can be released for use on patients.
In order to be approved for use in the USA, every device and drug will be required to be passed by the US Food and Drug Administration organisation (FDA). This highly detailed and technical procedure is called the FDA 510k clearance process.
The FDA 510k clearance process is a complex procedure which varies depending on the type of device or drug being submitted for approval.
Types of 510ks
There are three types of 510ks, namely traditional, special and abbreviated – the latter two, which were introduced to help streamline the process, can only be used under certain conditions.
According to the FDA website, all 510ks are required to be a comparison between the new device and an already legally marketed device.
Anyone submitting a new device for approval must first identify a similar device or devices to which the new device will be compared. This will preferably be one which is as similar to the new device as possible, and is usually one which has been recently approved itself.
The Submission Process
The documents required for entry into the submission process include the name of the device, its proposed trade name, and a common or classification name. You will be asked to decide on the classification of the device, its appropriate use (for example cardiovascular or dental), and product code.
Applicants also need to give a full and accurate description of the device, any specifications, special controls or standards, and photographs or drawings of the device should also be supplied.
There must also be a description of the device’s use, plus a comparison with a predicate device or devices, pointing out similarities and/or any differences, with full identification regarding the device’s materials, any design considerations, the energy expected to be used or delivered by the device, and a description of its operational principles.
As can be gathered, the process is a highly complex one and many applicants make use of a service such as that provided by www.fdathirdpartyreview.com to help make it go smoothly.
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