FDA's Regulatory Revisions: Business & Legal Impact on Industry, Part 2 – Medical Devices

In the second part of our series in collaboration with Skadden, Wayne chats with Rachel Turow, Head of Skadden's FDA Regulatory Practice; Bill Ridgway, Co-Head of Skadden's Global Cybersecurity and Data Privacy Practice; Michelle Gasaway, Partner in Skadden's Capital Markets Practice; and Carolyn Bruguera, Vice President and General Counsel at the Medical Device Manufacturers Association. Together, they discuss considerations for companies who manufacture, design and/or develop medical devices, including general wellness devices, regarding whether to submit a 510(k); how to proactively prepare for and anticipate complex regulatory, diligence and disclosure issues in preparing for a public offering, private financing or other transaction; the intersection of FDA regulation, privacy law, and cybersecurity in AI for wellness and medical devices; cybersecurity False Claims Act risk for technology and life sciences companies; privacy considerations for  those who collect information from wellness and medical devices; what companies in the space should watch for; and much more. This episode and the rest of our series do not include the usual Headlines and Resources Links segments. To 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 [email protected].  Music by Dvir Silver from Pixabay.