Matrix Requirements’ Post

(Benefit-Risk Management / Medical Devices / 2024 FDA Guidance List) This was released about a month ago so simply a fyi for those looking to see what future topics via draft or final guidances are expected in 2024 from FDA's Center for Devices and Radiological Health (CDRH). Enjoy. #fda #medicaldevices #guidance #cdrh

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Latest #FDA #meddevice Warning Letter with the top citation being in the area of Complaint Handling (820.198). This is a common citation and this WL details this firm's deficient process: "...fails to specify a definitive timeline to evaluate the complaint and reach out to the complainant." I recently observed this with a client where there wasn't a specific process to ensure follow ups to the complainant were documented. Having a well-defined process ensures you get accurate information to conduct a thorough root cause investigation. "...Additionally, the procedure does not describe the process for determining whether an investigation is necessary, and whether the complaint represents an event that is required to be reported to the FDA under 21 CFR Part 803 – Medical Device Reporting (MDR)." A hot 🔥 button with FDA (and any regulator for that matter) is not reporting instances of medical device-related serious injury or death. In this case, almost 100 complaints from 2021-2023 had not yet been evaluated for MDR reportability under 803. 😳 https://lnkd.in/e4wzqgUS ~~~ If you found this interesting, consider Reposting 🔄 and follow me Vincent F. Cafiso so you don't miss future content.

Many sessions at #RAPSConvergence 2023 reported on the US FDA and FDA electronic Submission Template And Resource (eSTAR). It may have been the penultimate session of the regulatory conference, though a meeting hall was packed to hear Patrick Axtell Ph.D., FDA, report on eSTAR. Read Emergo by UL’s Regulatory Update (Sarah Fitzgerald) on the FDA eSTAR, the interim data on the pilot program with Health Canada and eSTAR, and the International Medical Device Regulators Form (IMDRF) and eSTAR: https://lnkd.in/g57fRTpb. Again, we’re excited to report on eSTAR and the eSTAR and IMDRF! Thank you to our marketing team for supporting these updates on RAPS Convergence: Kathy Burke, Stewart Eisenhart, and Khalid Mandil. #medicaldevice #regulatory #regulatoryaffairs #regulatorycompliance #fda #eSTAR #EmergobyUL #weareULSolutions #welovewhatwedo #weloveglobalregulatory Emergo by UL’s Regulatory Updates on RAPS Convergence 2023: *Status of notified bodies: https://lnkd.in/dhGmkw7X. *IVDR and Clinical Evidence: https://lnkd.in/ggqCcPN8. *MDR and Clinical Evidence: https://lnkd.in/gBPBwCzy. *Notified bodies and changing: https://lnkd.in/g3SFPjmq.

Right you are Vincent F. Cafiso. Of great significance is the failure to provide evidence in the response to the 483. Don’t just say it, do it and provide evidence that you did, accompaing all your promises. This is where you are going to get your money worth by hiring someone that not only wrote a 483, issued it and followed up on it. By reading the Warning Letter specifically in between the lines as we say you can tell this firm did not have experience with the FDA and probably did not know what an appearance of a violation can do to their product at the border. Simply put a consultant like Mr. Cafiso would have advised write but underscore on the SOP certain points that were tagged on the 483 on compliants and glorify it with the MDR applicability. Gents this is serious business that of a 483, it tells you are on the radar and you got a target coordinate on your forehead. You already screwed up and you expect the agency to still trust you just because you are telling them you are going to correct the deviation. Trust but verify comes into play. Now we are at a different stage with a Warning Letter. Answering a Warning Letter raises the bar.

Another benefit of using InstyMeds is we submit all of the PDMP (Prescription Drug Monitoring Program) data on behalf of each facility. One less thing providers need to worry about! http://ow.ly/I5YQ50HCUzw #InstyMeds #PDMP #ControlledSubstances

Watch Out for Sound-Alike Medicines! It’s easy to mix up medicines with names that sound alike. This can lead to the wrong treatment and harm to patients. Staying careful and being aware of these risks helps keep patients safe. #pharmacy #medicationsafety #pharmd #patientcare

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Hear the experts talk about impact of ACNU and strategies to win

Looking forward to seeing new guidance on the use of RWE to support regulatory decision-making for medical devices in 2024! A timely addition to the docket. High on DTx's wish list for this guidance would be: - addressing the uses of RWE to modify an existing approved Intended Use (e.g. switching from prescription to OTC) - addressing the scenario where a product operating under an enforcement policy seeks to submit a 510k/De Novo and has accrued real-world data along the way Eagerly looking forward to seeing how this one coalesces.