Ken Block Consulting

Wondering about possible FDA submission delays caused by the Trump administration cutbacks? Please see the following quote from an email this morning from the lead FDA reviewer of one client's Q-Submission: "I am writing to provide you information regarding your submission. Due to unforeseen changes in staffing our team is working to realign priorities in order to meet the agency's mission of protecting and promoting public health. Consequently, the review timeline for some submissions may be extended beyond the timelines outlined in MDUFA or our public guidance documents. We are unable to clarify how long the review timeline will be extended for any impacted submissions at this time. We sincerely apologize for the inconvenience, and the FDA will continue to make every effort to conduct a timely review while managing incoming workload and other public health priorities."

An impressive new tool for brain assessment of patients with neurodegenerative disorders (including Alzheimer's disease) is entering the U.S. market! Through 510(k) clearance of the CDM Insights software device, our client Oxford Brain Diagnostics can now assess brain structure changes in U.S. patients by applying their unique measurements of brain microstructure and cortical thickness to MRI scans. Ken Block Consulting specializes in helping clients with novel technologies navigate their FDA pathway, and we are ready for our next challenge!

Busy 3 days at the huge MEDICA trade show in Düsseldorf, Germany! Met today with one of our European clients, to kick-start an urgent 510(k) project. In the meantime, we've been lining up FDA meetings for several Breakthrough Device clients and others. Ken Block Consulting (KBC) is available to develop the FDA regulatory strategy for your next device, including the need for any feedback from the regulators and/or whether your technology may qualify for Breakthrough or STeP (Safer Technologies Program).

KBC has a proven track record of getting excellent results for our clients! If your team could benefit from our expertise, please email us at [email protected] #fda #regulatory #medicaldevices #compliance

You may have noticed that the FDA introduced some changes in their eSTAR ‘Device Specific EMC Considerations’ as follows: - Text changed from ‘select the most severe risk’ to ‘select the most severe harm’ - Clarification that this question pertains to potential harm from the subject device only, and therefore the context of this question does not include harm that may be caused by any other nearby medical device - Clarification that the most severe harm should be assessed before mitigation measures, not after Why the change? It's because of KBC! Through direct exchanges with the FDA, we sought clarification regarding eSTAR device considerations. The FDA eSTAR team appreciated our input, saying: "We consulted internally about this and will be making changes in the next eSTAR update as a result. Thank you for your feedback, let us know if you find anything else." We were glad to help prompt improvements to this important eSTAR section! To view the eSTAR changes along with their importance and impact, please visit our website: https://lnkd.in/gcN28iC5 This update is one example of how KBC is at the forefront of FDA regulatory knowledge and practice, even influencing FDA expectations applying to all 510(k) medical device applications. If your company could benefit from our expertise, please reach out to us at [email protected]. #fda #regulatory #medicaldevice #estar #emc #510k

Today, Ken Block Consulting (KBC) earned our 5th Breakthrough Device Designation, this time for an implantable drug delivery device intended for pain treatment. Assisting a new (confidential) client who had made limited FDA progress over several years with a different consulting group, KBC reoriented the company’s regulatory approach. We started with setting an important goal of gaining entry to one of FDA’s special “fast track” programs. Working under the updated Breakthrough Devices Program guidance document that now allows devices that target pain and reduction of opioid use, our client’s innovative implantable drug delivery device now can benefit from the many benefits of Breakthrough Device Designation including frequent FDA consultations. The FDA review team described this new technology as “exciting” and the device as “exactly what FDA is looking for” to raise the U.S. Standard of Care (SOC) for the targeted patient populations. This success demonstrates an example of device technology that was previously eligible only for the FDA’s special Safer Technologies Program (STeP), but where that same technology may now qualify as a Breakthrough Device. Given the excitement and interest of the FDA review team, the FDA decision arrived on day 30 of what is usually a 60-day process. Our client is now lining up additional investment funds, which will help accelerate the final device validation and eventual De Novo submission (which – under the Breakthrough Devices program – will receive priority review). Please contact us ([email protected]) to discuss your company's novel medical device technologies, and how KBC can help you achieve FDA regulatory success!