In addition to our ISO/IEC 17025:2017 and FDA ASCA accredited acoustic power measurement, calibration, and testing laboratory led by Nick Ellens, Ph.D., Acertara’s regulatory team also partners with our valued customers on a worldwide basis who require assistance in developing and preparing the 510(k)-submission content for their diagnostic ultrasound devices. From specific submission consulting strategies to a full turn-key 510(k) submission our regulatory team can streamline and expedite the clearance process for your device. Over the last twenty plus years Acertara has been directly involved in the successful filing of more than seven hundred 510(k) submissions for ultrasound systems, probes, active implantables, and other ultrasound related devices.
Leading our ultrasound 510(k) device clearance and submission services are G. Wayne Moore, B.Sc., MBA, FASE, FAIUM, CEO of Acertara, and Callie Moore, M.Sc., RAC, Acertara’s Senior Director of Quality and Regulatory Affairs. Wayne Moore has received comprehensive training as an ISO Lead Auditor, is the 2022 Chair of the NEMA/MITA Ultrasound Section and is a Fellow of the American Society of Echocardiography (FASE) and a Fellow of the American Institute of Ultrasound in Medicine (FAIUM). In addition to being Regulatory Affairs Certified (RAC), Callie Moore earned her Master of Science Degree from the George Washington University School of Health Science, with a focus on regulatory affairs. Please contact Acertara for ultrasound 510(K) device clearance and the following regulatory needs – we are ready to help.
A Sample of Submission Services Available:
- Specific Topic Research, e.g., optimal predicate device and market research
- FDA Liaison: Q-Subs, during submission process (RAI’s), and post-market Surveillance
- Market Clearance Strategies – timing, pathways, and submission language guidance for ultrasound device 510(k) clearance
- Assist with writing and assembling the submission
- Turnkey 510(k) Submission – assembly/filing/tracking from initial submission through device clearance
- Assist with other required Guidance sections, e.g., developing User Manuals
- Proof-read and analyze for adequacy of content within the submission prior to sending to the FDA