Medical Device Oversight in a Changing Landscape – FDA Watch
Wayne chats with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani, and Bobbi Druyor-Sanchez, Partner with NDA Partners. You’ll hear their thoughts on what’s happening at CDRH with warning letters and inspections for medical devices, AI-enabled medical devices and the ongoing situation with Whoop, and much more.
Headlines
Pharma: U.S. District Court upholds FDA authority to regulate homeopathic drugs as “new drugs” under the FD&C Act
Pharma: HHS brings back task force on childhood vaccines
Devices: FDA declares PFAS in medical devices safe
Food: FDA issues warning about imported cookware that may leach lead into food
Cosmetics: In recent webinar, experts outline growing complexity of biodiversity compliance for cosmetics and personal care companies
Resource Links
Pharma: FDA posts update to help consumers better understand agency-related terms for possible new therapies
Devices: Despite FDA request to pull blood pressure tracking tool, wearable-maker Whoop Inc said it will not
Cosmetics: Independent Beauty Association interactive U.S. Legislative and Regulatory Policy Map
About Our Guests
Neil O’Flaherty
Neil O’Flaherty is a seasoned veteran with over 28 years of legal experience representing medical devices and other clients regulated by FDA. Companies from multinational firms to start-ups look to Neil for key guidance and assistance because of his strong substantive knowledge of complex FDA requirements and policies and his ability to provide insightful advice, allowing firms to succeed and accomplish their business goals in a highly regulated industry. Neil is also highly sought after as an accomplished and effective advocate and “problem-solver” for his clients when they face compliance, enforcement, and other issues with FDA and other regulators, including governmental investigations and inquiries. Neil also has extensive experience in shepherding clients through recalls and other field actions involving distributed product.
In addition to product manufacturers, Neil routinely represents distributors, trade associations, hospitals, venture capital, and private equity groups. He has even provided advice and counsel to a foreign governmental entity.
Bobbi Druyor-Sanchez
Bobbi Druyor-Sanchez, MS, is a Partner with NDA Partners and has worked with the company as an Expert Consultant since 2014. She is a bioengineer with expertise in both regulatory affairs and quality assurance with an emphasis on software as a medical device (SaMD), telemedicine, ophthalmic, and supporting the convergence of CLIA based Laboratory Developed Tests (LDT) to FDA in vitro diagnostic tests including bioanalytic implementation. This includes defining technical and product direction in early-stage companies, 510(k) and De Novo clearance submissions, implementing medical device quality systems including QSR, ISO 13485, and MDR/CE Mark Certification Quality Management Systems (QMS).
Bobbi was formerly Director of Quality and Regulatory at MedApps Inc./Alere Connect, and Vice President of Quality and Regulatory at Exsomed. Before joining MedApps, she was Director of Systems Integration Engineering at Rose Street Labs/Kemeta LLC, and has held senior engineering positions at Ventana Medical Systems and Motorola/Amersham/GE Healthcare, IMPRA (a subsidiary of C.R. Bard). For three years she was part of the mHealth (MRC) and CDS Coalitions, whose goal was to be a thought leader in mHealth and Clinical Decision Software ecosystems. These Coalitions worked with FDA, FCC, and IT Health to define policy such as the new MDDS and MMA guidances as well as the FDASIA report.
FDA Watch Podcast 