What’s Coming in Device, Cybersecurity, and Digital Health Product Regulation

What's Coming in Device, Cybersecurity, and Digital Health Product Regulation – FDA Watch

In this episode, Shelly and Wayne chat with Neil O'Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP, and John Swayer, President of Realistic Quality Solutions, LLC. You'll hear their thoughts on the top priorities in medical device regulation for the next FDA Commissioner and their insights on laboratory-developed tests, the transition to ISO 13485, cybersecurity guidance and regulation, and digital health product regulation. In our headlines segment, Shelly and Wayne delve into these major developments: Pharma: FDA Issues Draft Guidance on Accelerated Approval of Drugs for Serious Conditions Devices: FDA Publishes Report on Risks and Benefits to Health of Non-Device Software Functions Food: USDA and FDA Announce Joint Request for Info on Food Date Labeling Cosmetics: FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products In our Resource Links segment, we listed key documents in our four core areas. To view these links, subscribe, or find out more information about our podcast, visit FDAWatch.net. Want to be a sponsor, marketing partner, or guest, or provide feedback on the podcast? Email us at info@fdawatch.net. Music by Dvir Silver from Pixabay.

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In this episode, Shelly and Wayne chat with Neil O’Flaherty, Partner and Head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP, and John Swayer, President of Realistic Quality Solutions, LLC. You’ll hear their thoughts on the top priorities in medical device regulation for the next FDA Commissioner and their insights on laboratory-developed tests, the transition to ISO 13485, cybersecurity guidance and regulation, and digital health product regulation.

Headlines

Pharma: FDA Issues Draft Guidance on Accelerated Approval of Drugs for Serious Conditions

Devices: FDA Publishes Report on Risks and Benefits to Health of Non-Device Software Functions

Food: USDA and FDA Announce Joint Request for Info on Food Date Labeling

Cosmetics: FDA Updates Guidance for Industry on Registration and Listing of Cosmetic Product Facilities and Products

Resource Links

Pharma: Guidance document on accelerated approval and expedited program for patients with serious conditions

Devices: MDMA Comments to FDA on Predetermined Change Control Plans for Medical Devices

Food: FDA In Your Day video on FDA’s recent reorganization, work of the Office of Inspections and Investigations, and the Unified Foods Program

Cosmetics: PCPC article on counterfeit cosmetics

About Our Guests

Neil O’Flaherty

Neil O’Flaherty has over 34 years of legal experience representing medical device clients regulated by the U.S. Food and Drug Administration (FDA). He is a Partner and the Head of the Medical Device Practice Group at Amin Wasserman Gurnani LLP. Neil is an advocate for his clients when they face compliance, enforcement, and other obstacles with FDA.  Neil assists clients with Class I, II, or III medical devices at any stage in their product’s premarket and commercial lifecycle.  

John Sawyer

John Sawyer is a medical device expert in quality management systems and regulatory affairs. His experience has focused on regulatory affairs, quality assurance, risk management, clinical affairs, and now cybersecurity.  His current work has been establishing and improving quality systems and regulatory strategies for various modalities based on FDA’s QSR, ISO-13485, EU MDR, and CMDCAS.

He has spent time with firms both domestically and internationally for Class I, II, and III devices. He has his BA and MBA in Business Administration & Management.