<h1 class="entry-title">Category: Uncategorized</h1>

FDA U.S. Agent Services

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 […]

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March 22, 2023 Nonconforming Expiration Date   In short, if erroneous / outdated / violative / incorrect expiry date (or other related data on the label) are within reasonable risk acceptance criteria (safety, performance, regulatory), then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 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 […]