In our first article, we talked about the overall FDA 510(k) clearance process, determining classification, identifying the right FDA product code, and finding suitable predicate devices.In this post, we will focus on how to determine which guidance documents and international standards may be applicable to your device. The US Food and Drug Administration (“FDA”) recently issued four final guidance documents related to 510(k) medical device programs. After you have read the description associated with the regulation number and are absolutely certain that the product code DPW is the correct one, then go the FDA’s 510(k) database and search for any devices cleared under product code DPW.. FDA recommends that manufacturers use a risk-based assessment approach to determine whether a new 510(k) is likely required, as outlined in FDA’s guidance “Deciding When to Submit a 510(k) for a Change to an Existing Device”. 510(k) Transfer of Ownership . Choosing the Right Predicate Device for Your 510(k) Submission. The FDA provides an array of 510(k) guidances, including device-specific guidance and general guidance documents. Device-specific guidances describe the information you need to prove substantial equivalence. The agency recognizes that manufacturers make many changes to their devices each year and often question whether to submit new 510(k… Review the documents relevant to your product. The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance entitled “The Special 510(k) Program.” FDA established the Special 510(k) Program to facilitate the submission, review, and clearance of changes to a manufacturer's own legally marketed predicate device. The guidance documents relate to the Special 510(k) and Abbreviated 510(k) Programs, as well as the Format for Traditional and Abbreviated 510(k)s, and the Refuse to Accept Policy for 510(k)s. Guidance for Industry and FDA Staff Use of Symbols on Labels and in Labeling of In Vitro Diagnostic Devices Intended for Professional Use, dated November 30, 2004 eCopy Program for Medical Device Submissions, Guidance for Industry and FDA Staff, dated December 31, 2015 Refuse to Accept Policy for 510(k)s, dated January 30, 2018 The FDA published a draft guidance entitled “Transfer of a Premarket Notification (510(k)) Clearance—Questions and Answers” in December 2014 (See, Docket No. FDA 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval (PMA). This is where things can get tricky and you need to be careful. 510(k) Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims. On August 5, 2016, the US Food and Drug Administration (FDA) posted two long-awaited draft guidance documents intended to help industry and FDA staff determine whether a new premarket notification (510(k)) is required upon the modification of a legally marketed medical device. A 510(k) for a medical device can be thought of as like a patent making a 510(k) transfer of ownership, say following a sale, for example, a particularly important process to follow. Step 5: Choose a Format. FDA’s Refuse to Accept (RTA) guidance includes acceptance checklists for traditional as well as Abbreviated and Special 510(k) application routes. FDA's recently issued guidance provides the agency and industry a common ground for determining when to submit a new 510(k) for changes to an existing device. Last, FDA has finalized guidance updates from early 2019 to the agency’s Refuse to Accept policy that establishes minimum acceptability thresholds for medical device 510(k) submissions. FDA-2014-D-1837). The draft guidance does not explain how FDA will distinguish the 510(k) holder from others required to list the same number, but presumably these distinctions will be drawn based upon the activities of the listing party (e.g., if a sterilizer lists the 510(k) number, FDA will infer that it does not claim to be the 510(k… A 510(K) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act) that is not subject to premarket approval. TIP: We’ve combined all three blog posts into a single PDF.
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