Steve Gompertz’s Post

🖋 This week's Warning Letter provides shining examples of how NOT to respond to the FDA ... 🛑 Don't ignore any communication from the FDA. When that certified letter shows up, you better open it fast, and don't think the fifteen business days to respond are only a suggestion. 🛑 Don't ignore the FDA's follow-up email! Emails are just as official as certified letters. 🛑 Don't respond to the second follow-up email by trying to tell the FDA that they're mistaken about your product being a device or drug. 🛑 Don't double down when the FDA tells you you're wrong by further trying to defend your faulty logic.  ➡ In this case, the Manufacturer tries to explain that their product doesn't interact directly with "humans or individuals." 🤔 We're unsure what the distinction is, but let's not get distracted. The Manufacturer further clarifies that their product only applies to sanitizing and washing tools and accessories. Swing and a miss! ⚾ 😥 Yeah, there's that relatively straightforward wording in the FD&C Act indicating that components, parts, and accessories are indeed within its scope. You simply aren't going to win a debate with the FDA on interpretation of the Act or other regulations. Here's hoping we get to see the manufacturer's next response, assuming they understand the fifteen-day deadline to do so. When that first communication is received, it's time to immediately engage experts like those at QRx Partners to guide you on responding effectively. 🤝 Read the full FDA Warning Letter here 👉 https://lnkd.in/ggqM-w-N #QRxPartners #QRxInforms #MLV #InadequateResponse #WarningLetters #FDA #FDAwarning #FDAcompliance #regulatory #CDRH #MedicalDevices #quality #HereForYou

🖋 This week's Inadequate Response appears to be another themed week for FDA Warning Letters, and according to three recently released warning letters, that theme is syringes. 💉 Two of them appear to be related, and the third indicates what appear to be common violations for this type of device. The connective tissue between these warning letters initially seems fairly clear but becomes muddied the more you try to follow the details. 💉 One organization appears to be the foreign manufacturer, and another is the specification developer and importer. When you look at the specific violations, they start with the manufacturer's lack of clearance or approval submissions, followed by a failure to resubmit upon making significant design and intended use changes. The third seemingly separate organization is cited for the same type of violations. 💉 Regardless of their connections, all three organizations made the same common mistake of assuming that 510(k) clearance is forever and somehow allows freedom to modify the device and its intended use without any regulatory burdens. 😳 💉 To us, one of the more subtle lessons here is that even when the device and its design are relatively simple, it is still possible to have changes that fit the FDA's definition of a significant change. 👉 Our theme, week after week, is once again that when you operate in the regulated space, you can't think that you understand your regulatory obligations; you must know them. As always, seeking expert guidance will be well worth the investment cost. 🤝 Let QRx Partners be your prescription for avoiding these regulatory "ailments". The three Warning Letters can be viewed below... 1️⃣ https://lnkd.in/gi-QR9_s 2️⃣ https://lnkd.in/gfqXz3SF 3️⃣ https://lnkd.in/gyzMTTpG #QRxPartners #QRxInforms #mlv #InadequateResponse #fda #fdacompliance #warningletters #cdrh #medicaldevices #compliance #regulatory #regulatorycompliance #experts

Hey everyone, Darren here with another DP Minute you don’t want to miss! Today, we’re breaking down Comment #81 from the QMSR Preamble discussions. The FDA has received feedback on their plan to replace the QSIT guide (Quality System Inspection Technique) with a new inspection approach aligned with QMSR requirements. Commenters also suggested that the FDA use IMDRF (International Medical Device Regulators Forum) guidelines and consider risk-based factors. The FDA hasn’t shared much about their future inspection model yet, but they’re working on it! From what we’ve gathered, it’s going to focus on high-risk areas during inspections. Check out the video for more insights! If you have questions or want to explore this further, reach out to us via LinkedIn or visit DPDConline.com. Let’s connect and continue the conversation. #QMSR #QSIT #FDA #IMDRF #MedicalDevices #RiskBasedInspections #DPDConsulting #DPDC #MedicalDeviceRegulatoryConsulting #ISO13485

Hey everyone, it's Darren Reeves from DP Distribution & Consulting, LLC® back with another DP Minute for you. The FDA sifted through around 100 comments, boiled them down to 83, and they've addressed each one. In Comment No. 17, some folks wondered why the FDA decided to change the regulation when the QS Regulation and ISO 13485 are very similar. The FDA is looking to align with ISO 13485, aiming for regulatory simplicity and global harmony. Watch the attached video to learn more.  Visit our website, dpdconline.com, or drop us a direct message on LinkedIn to let us know how we can support or partner with you. Let's navigate this compliance journey together. #QMSRPreamble #MedicalDeviceRegulation #QSRegulation #MedicalDevices #ISO13485 #FDA #MedicalDeviceRegulatoryConsulting #DPDConsulting #QMSR

📢 Loper Bright Renews Interest in the VALID Act 📢 The recent Loper Bright ruling could spark new momentum for the VALID Act, impacting laboratory-developed tests (LDTs) and FDA oversight. 🧪⚖️ Check out Christine P. Bump’s insightful analysis on what this means for labs and regulatory compliance. Don't miss it! 🔗 Read the full article: https://bit.ly/3ATWLW1 #LabRegulations #VALIDAct #LDTs #FDACompliance

🎃 Don't get spooked by FDA regulations this Halloween! 👻 At Concise Engineering, we're here to take the scare out of compliance. Our expert team will guide you through the regulatory maze, ensuring your product meets FDA standards without the fright. Let us help you turn those regulatory nightmares into a smooth, stress-free process! 🧙♂️🎃 #fda #FDACompliance #NoMoreScares #RegulationReady #medtechman

🎃 Don't get spooked by FDA regulations this Halloween! 👻 At Concise Engineering, we're here to take the scare out of compliance. Our expert team will guide you through the regulatory maze, ensuring your product meets FDA standards without the fright. Let us help you turn those regulatory nightmares into a smooth, stress-free process! 🧙♂️🎃 #fda #FDACompliance #NoMoreScares #RegulationReady #medtechman

🎃 Don't get spooked by FDA regulations this Halloween! 👻 At Concise Engineering, we're here to take the scare out of compliance. Our expert team will guide you through the regulatory maze, ensuring your product meets FDA standards without the fright. Let us help you turn those regulatory nightmares into a smooth, stress-free process! 🧙♂️🎃 #fda #FDACompliance #NoMoreScares #RegulationReady #medtechman

If you missed the FDA's webinar last Tuesday about the final rule on LDT regulation, it is now available on CDRH Learn. You can find the video there https://lnkd.in/egFrgrxK

𝗪𝗵𝗮𝘁 𝗶𝘀 𝗙𝗗𝗔 𝟰𝟴𝟯? 𝗜𝗺𝗽𝗼𝗿𝘁𝗮𝗻𝘁 𝗗𝗲𝘁𝗮𝗶𝗹𝘀 𝗔𝗯𝗼𝘂𝘁 𝗙𝗗𝗔 𝟰𝟴𝟯 𝗙𝗼𝗿𝗺𝘀 The FDA 483 form plays a crucial role in safeguarding consumer health by ensuring that products manufactured and circulated in the US market meet strict quality and safety standards. In this article, GOL will provide you with important information about the FDA 483 form, including its contents, issuance process, response methods, and consequences of non-compliance. Full story: https://lnkd.in/eWxg_abg