March 10, 2023 FDA UDI for Class 1 510(k)-Exempt Devices I recently received an inquiry about the UDI implications of a device that the Labeler had previously miscategorized. FDA’s class-based UDI requirements are governed by the way FDA (i.e., the applicable U.S. classification regulation) categorizes/classifies the subject device; not by how the Labeler categorizes the subject […]
<h1 class="entry-title">Category: FDA</h1>
FDA 21 CFR Part 7 vs. Part 806: What’s the Difference?
March 8, 2023 FDA 21 CFR Part 7 vs. Part 806: What’s the Difference? And as you deliberate on the nature of your proposed field gesture, remember first that 21 CFR Part 806 is not the regulation for categorization, evaluation, or initiation of any recall. Instead, FDA intends Part 806 to be for assuring proper […]
That Advisory Notice Might be a Recall
March 8, 2023 That Advisory Notice Might be a Recall I received a question today wondering if user facilities should be notified to quarantine devices if a device safety issue is suspected. The answer is yes, but with great care. Specifically, if a device safety issue suspected with distributed units, then the manufacturer certainly […]
FDA 510(k) Modifications – Inclusion of Non-Triggering Change Details
March 3, 2023 FDA 510(k) Modifications – Inclusion of Non-Triggering Change Details If multiple changes have been made to the subject device since the prior 510(k), but where only one/some of those changes trigger(s) the need for a new 510(k), and if the aggregate of changes isn’t what’s triggering the need for the new 510(k), then […]
Recall Classification: U.S. FDA
February 20, 2023 Recall Classification: U.S. FDA For the U.S. FDA, a risk-based approach is required for categorizing a recall; for planning and implementing a recall (e.g., to assure proper recall depth and effectiveness); for resolving the issues that caused the recall; for writing the recall notification, etc., etc. First, a proposed remedial […]
Recall Initiation in the U.S.
February 17, 2023 Recall Initiation in the U.S. In most cases, FIRMS initiate recalls rather than FDA: If U.S. recall trigger criteria are met, then FDA generally requires that FIRMS initiate recalls. FDA’s corresponding regulation is called “Firm-initiated recall” and is located at 21 CFR §7.46. See also FDA’s corresponding recent guidance document, […]
FDA 21 CFR Part 7 vs. Part 806: What’s the Difference?
January 26, 2023 FDA 21 CFR Part 7 vs. Part 806: What’s the Difference? The most succinct way I’ve seen FDA correlate 21 CFR Part 806 with 21 CFR Part 7 is by stating that Part 806 reports of corrections and removals are required for Part 7 Class I and Class II recalls, yet […]
Intended Use vs. Indications For Use: What’s the Difference?
August 5, 2021 Intended Use vs. Indications For Use: What’s the Difference? Successful premarket regulatory strategy and authorizations weigh heavily on proper understanding between the term “Intended Use” as distinguished from “Indications for Use”. That said, it can be difficult to find clearly defined explanations of these terms. For the U.S. FDA jurisdiction, I […]
FDA’s 21 CFR §820.72 Metrology Requirements vs. Test Method / Process Validation
July 29, 2021 FDA’s 21 CFR §820.72 Metrology Requirements vs. Test Method / Process Validation My experience has been that FDA views a test method as a process that produces an output. And if such output can’t be fully verified, then it must be validated. Since FDA’s 21 CFR §820.72 is not generally related […]
FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage
July 27, 2021 FDA MDUFMA Small Business Determination (SBD) at the Pre-Revenue Stage Before addressing FDA’s MDUFMA fees and SBD program for a firm’s premarket submission when at a pre-revenue / premarket stage, my suggestion is to first remember that if a product clearance or approval [510(k) clearance, PMA approval, etc.] hasn’t happened yet, […]