The test data obtained from these different tests is included in the 510(k) submission. The FDA requires extensive testing for electrical safety, electromagnetic compatibility and biocompatibility, as well as other specialized tests that may be applicable, for home-use devices. A popular example of such a product is a hand-held, light-based laser device to treat full-face wrinkles. Devices sold over-the-counter (OTC) or by prescription are usually self-administered by a layperson in a home setting. Home-use devices often present hazardous situations for the layperson. To help manage the risk a device poses to a patient or user, the FDA imposes their regulatory controls on the manufacturer of the device, which vary by classification. A PMA requires clinical data, as well as performance data, to prove safety and effectiveness. Most Class I devices are exempt from the 510(k) process, while most Class III devices require Premarket Approval (PMA), which is a more rigorous regulatory pathway than a 510(k). Many devices are actually tested to worst case conditions to assess the risk of extreme use situations. One way to accomplish this for moderate to high-risk devices is to test the device against a known standard(s) that subjects it to simulated use conditions. The entity named on the device’s label is responsible for managing those risks, and demonstrating that their device is both safe and effective for its intended use. All medical devices have a certain degree of risk associated with their use, as no device is considered perfectly safe. Class I devices pose the least risk to the user, while Class III devices pose the highest risk. The FDA has three classes for medical devices (Class I, Class II, and Class III) based on the level of risk the device poses to the user. They must also complete all design and development activities as defined in 21 CFR Part 820.30, Design Controls, as any test data submitted in a 510(k) should be conducted on a finished device, or a device that fully represents the final design. FDAīefore a device sponsor can determine the testing requirements for their device, they must correctly classify their device according to the FDA’s Product Classification database.
#Fda 510k database how to#
We will discuss how to identify the correct testing requirements and performance standards for your device using FDA databases, as well as other methods to determine relevant testing information for predicate devices outside normal FDA databases.Ĭlassifying Your Medical Device under the U.S.
This article does not cover how the FDA uses recognized consensus standards to make substantial equivalence determinations in 510(k) submissions. If you cannot provide the requested test data in a timely manner, you might even have to withdraw your 510(k) submission. Failure to do so could result in a longer 501(k) review time if the FDA sends an Additional Information (AI) request, asking for test data that was not anticipated or budgeted. It is very important to identify the correct testing requirements. While testing requirements are easy to determine for some devices, other devices require intensive research. Identifying the Correct FDA Guidance Documents and StandardsĬ lients who engage us for FDA 510(k) submission consulting often ask what testing is required by the FDA to clear their device.
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