Timothy Kelley

𝗙𝗗𝗔 𝗖𝗿𝗮𝗰𝗸𝘀 𝗗𝗼𝘄𝗻 𝗼𝗻 𝗗𝗮𝘁𝗮 𝗜𝗻𝘁𝗲𝗴𝗿𝗶𝘁𝘆 𝗳𝗿𝗼𝗺 𝗧𝘄𝗼 𝗖𝗵𝗶𝗻𝗲𝘀𝗲 𝗧𝗲𝘀𝘁 𝗟𝗮𝗯𝘀 📣📣 The FDA’s Center for Devices and Radiological Health (CDRH) has taken decisive action against two Chinese third-party labs—Mid-Link https://lnkd.in/ewejwei5 and SDWH https://lnkd.in/ez2nTdR8 —after discovering falsified and invalid data used in premarket medical device submissions. 🔬📉 🔍 𝗪𝗵𝗮𝘁’𝘀 𝗛𝗮𝗽𝗽𝗲𝗻𝗶𝗻𝗴: ·       The FDA has issued General Correspondence Letters to both labs. ·       All biocompatibility and animal safety/performance data from these facilities will now be 𝗿𝗲𝗷𝗲𝗰𝘁𝗲𝗱 by the agency for use in premarket device submissions. ·       This follows 2024 warning letters citing oversight failures and animal welfare violations. 💬 “The FDA has no room for bad actors,” said Commissioner Dr. Marty Makary. “Falsified data can jeopardize access to devices, harm the supply chain, and mislead product sponsors.” 📢 𝗧𝗮𝗸𝗲𝗮𝘄𝗮𝘆 𝗳𝗼𝗿 𝗠𝗲𝗱𝗶𝗰𝗮𝗹 𝗗𝗲𝘃𝗶𝗰𝗲 𝗖𝗼𝗺𝗽𝗮𝗻𝗶𝗲𝘀: If you’re outsourcing your testing—especially internationally—𝘀𝗰𝗿𝘂𝘁𝗶𝗻𝗶𝘇𝗲 𝘆𝗼𝘂𝗿 𝘁𝗵𝗶𝗿𝗱-𝗽𝗮𝗿𝘁𝘆 𝗱𝗮𝘁𝗮. The FDA expects 𝘵𝘳𝘶𝘵𝘩𝘧𝘶𝘭, 𝘢𝘤𝘤𝘶𝘳𝘢𝘵𝘦, 𝘢𝘯𝘥 𝘪𝘯𝘥𝘦𝘱𝘦𝘯𝘥𝘦𝘯𝘵𝘭𝘺 𝘷𝘦𝘳𝘪𝘧𝘪𝘦𝘥 information in every submission. 🔗 Related Sept 2024 letters & related links: https://lnkd.in/eQFXF3TZ #MedicalDevices #DataIntegrity #FDA #RegulatoryCompliance #Biocompatibility #ThirdPartyTesting #CDRH #RiskManagement  

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⚡Interested in seeing how other successful organizations have conducted their MRMC and Standalone studies? Here's how DeepHealth used Special 510(k) for Saige-Dx expansion. Original Clearance: K220105 (Traditional 510(k)) MRMC Study: 1. 18 MQSA readers 2. 240 cases 3. ≥4-week washout Standalone Study: 1. 1,304 cases 2. 9 U.S. sites 3. The Evolution: K251873 (Special 510(k), 2025) New Standalone Study: 1. 2,002 DBT mammograms 2. Multi-vendor: Hologic & GE 3. Non-inferiority vs predicate (K243688) 4. Prior MRMC evidence remained applicable The strategic brilliance: 1. Used Special 510(k) pathway for manufacturer expansion 2. Leveraged existing MRMC data 3. Only needed fresh Standalone for new vendors 4. Ongoing standalone accrual enabled this fast modification The lesson: Initial clearance: Both MRMC + Standalone Future expansions: Standalone only (when MRMC precedent exists) This is how you build modular regulatory strategy. One MRMC. Multiple Standalone expansions. 🔗 See the complete Special 510(k) framework: https://hubs.li/Q03NCMC_0 #MedTech #Mammography #ClinicalAI #SaMD #FDAClearance #510k #RegulatoryStrategy

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Transform diagnostics at DOD and VA Dental Clinics with the Carestream CS 9600 CBCT scanner, proudly supplied by Contemporary Product Solutions (CPS). This state-of-the-art system delivers AI-powered precision with crystal-clear 3D images at up to 86% lower radiation than traditional 2D scans, ideal for high-stakes government settings. Its 5-in-1 scalable design offers 14 fields of view (4cm x 4cm to 16cm x 17cm), supporting everything from endodontics to implant planning. The Scan Ceph module and CS MAR feature reduce artifacts for unmatched clarity, streamlining workflows for busy clinics serving our veterans and service members. At CPS, we deliver with a 98% on-time rate, ensuring compliance and reliability for government contracts. Ready to upgrade your diagnostics and partner with a trusted supplier? Connect with us at https://lnkd.in/eYZ-BSgp #DentalImaging #GovernmentContracting #VeteranSupport

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I’m pleased to share my recent article in Orthopedic Design & Technology on a topic that’s becoming central to medical innovation — cybersecurity in connected medical devices. As digital connectivity expands across the orthopedic and broader medtech ecosystem, cybersecurity has become a core component of patient safety, regulatory compliance, and product reliability. The article explores how device manufacturers can take a proactive, lifecycle-based approach to managing these risks. Appreciate ODT for spotlighting this critical and evolving area.

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Pakistan’s diabetes crisis is accelerating, with one of the highest prevalence rates globally and a parallel rise in preventable amputations. While clinical factors are well known, an often-ignored social determinant is living alone. Diabetes — especially diabetic foot disease — requires daily vigilance, early detection, and timely help. Patients who live alone frequently present late with advanced infections, miss early warning signs due to neuropathy, and struggle with self-care and follow-ups, dramatically increasing amputation risk. This challenge is amplified by Pakistan’s gradual shift away from the traditional joint family system, which once provided built-in caregiving, early problem recognition, and emotional support. As social isolation increases and family-based care declines, amputations become not just a medical failure but a social one. Reducing limb loss in Pakistan will require more than better treatment — it demands recognition of social risk factors, stronger community support, and healthcare models that adapt to our changing social fabric.

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