![]() ![]() While FDA prefers if manufacturers comply with FDA-recognized standards, conformance is voluntary unless the standard is specifically referenced in a regulation. Is it necessary to perform any new tests if applicable?Ī:FDA does not require conformance to the latest standard version for your testing, so you will not have to reconduct testing with the release of the latest standard. Q: I have a question regarding complying to the latest standard version after getting the 510(k) clearance. #FDA 510K DATABASE HOW TO#It is important to understand the difference and the importance of how to word each statement. Many times there could be overlap of the intended use and indications for use and both statements could be similar or even the same. ![]() The indications could then specify painful joint disease due to osteoarthritis, varus/valugus deformity, and post-traumatic loss of joint function. For example, total knee replacements could be intended to be used as a total knee replacement in patients with knee joint pain. The indications for use describes the patients and conditions the device is used for. Q: What is the difference between intended use and indication of use?Ī: Intended use describes what your device does and encompasses the indications for use. One example is the medical support stocking (21 CFR 880.5780) listed in our presentation! A complete list of 510(k) exempt devices can be found here. Q: Hi, Could you please give example of 510(k) exempt device?Ī: There are many class 1 and class 2 devices that are 510(k) exempt. A risk-based assessment should be used to evaluate the change to determine if the effect of the change is considered significant or modifies the intended use of the device. #FDA 510K DATABASE SOFTWARE#We recommend referring to Guidance Document "Deciding When to Submit a 510(k) for a Change to an Existing Device" () and/or "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (), both issued on issued on October 25, 2017, for specific examples and additional information. ![]() (ii) A major change or modification in the intended use of the device." Material, chemical composition, energy source, or manufacturing process. Or effectiveness of the device, e.g., a significant change or modification in design, (i) A change or modification in the device that could significantly affect the safety The following constitute significant changes or modifications that require a premarket notification: Q: What are the requirements for Letter to File?Ī: 21 CFR 807.81(a)(3) states that a change should be submitted to FDA when a currently marketed device is "about to be significantly changed or modified in design, components, method of manufacture, or intended use. Here's a linkwhere you can register for the on-demand webinar (and download the slides) if you have yet to do so. In this blog post, we share some answers to those questions and hope you find them helpful. The questions we received related to January's webinar were phenomenal. Part one addressed Class I and Class II devices, while part two (TBA in the spring) will cover Class III devices. #FDA 510K DATABASE SERIES#R&Q's first webinar of 2020 was the first in a two-part series on bringing your medical device to market in the United States. ![]()
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