December 8, 2023 FDA U.S. Agent Services My firm regularly acts as the U.S. Agent for our international clients, so we have lots of experience with that. In general, the foreign firm in its own FURLS registration records must first designate the U.S. Agent. Then the prospective U.S. Agent receives a notification to […]
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Don’t Claim Device MR Compatibility Until You’ve Earned It
April 6, 2023 Don’t Claim Device MR Compatibility Until You’ve Earned It For the United States, if a device doesn’t yet have FDA-cleared/approved MR labeling, then it would constitute misbranding (illegal labeling) if a letter or other promotional or instructional information is sent to customers stating that the device is MR safe. In short, […]
Nonconforming Expiration Date
March 22, 2023 Nonconforming Expiration Date In short, if erroneous / outdated / violative / incorrect expiry date (or other related data on the label) are within reasonable risk acceptance criteria (safety, performance, regulatory), then such product can be accepted as-is and left alone. But if the risk acceptance criteria are exceeded, then corrective […]
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 […]
FDA 510(k) Predicate Strategy Tip
February 28, 2023 FDA 510(k) Predicate Strategy Tip If your chosen predicate is a prior 510(k)-cleared version of the subject device, then such predicate is generally the best option.
FDA 510(k) Change Strategy: Reprocessing-Focused
February 28, 2023 FDA 510(k) Change Strategy: Reprocessing-Focused If the only thing that has changed is the reprocessing process, then the substance of the new 510(k) can just be focused on the aspects that changed. In other words, no need to restate the device description, software contents, etc., etc., that aren’t affected by the […]
Real-Time or Accelerated Aging?
February 22, 2023 Real-Time or Accelerated Aging? As a general rule in the medical device sector, accelerated aging data is expected to be ultimately backed up with real-time data. Consequently, we still generally need to have real-time data to support whatever (let’s say, a 6-year) shelf life we are targeting. If for example we […]
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, […]
Showing Conformity to Standards
July 16, 2021 Showing Conformity to Standards Regardless of the source of a request for evidence showing conformity with applicable standards, a pivotal underlying fundamental remains the same and drives the answer: Conformance with standards is generally a design/development verification and/or validation activity. Therefore, the general rule of thumb is that there needs to […]
EU MDR Scope and Applicability of GSPR 10.4.1
July 12, 2021 EU MDR Scope and Applicability of GSPR 10.4.1 I think there is a good possibility that GSPR clause 10.4.1’s reference both to “invasive” and to “come into direct contact with the human body” may just be an ambiguous redundancy in describing invasive devices, as I have a hard time imagining an […]