This week on Trying to Keep Up, Allison Komiyama and Michael Nilo dive into another busy week in medical device regulation, highlighting new FDA activity affecting sponsors, startups, and regulatory professionals.

The conversation begins with the newly authorized Claria System, a De Novo-cleared minimally invasive hysterectomy device designed to improve tissue extraction while reducing recovery time and patient risk. Allison explains the history of power morcellation, why containment systems matter, and why this authorization represents an important advancement for women's health technology.

The team discusses the FDA's latest women's health communications surrounding metals detected in tampons and menstrual products, explaining why "detected" does not necessarily mean "dangerous" and how FDA toxicology research helps put alarming headlines into context. They also emphasize Marina Dinekho's thoughtful perspective on risk communication and biocompatibility.

A major topic this week is FDA's proposed Medical Device User Fee Amendments (MDUFA VI), including the possibility of charging user fees for Pre-Submissions, new focused follow-up pre-submission meetings, earlier sponsor interactions for De Novo submissions, and the upcoming public meeting on MDUFA reauthorization. The conversation highlights the value of Pre-Subs, when companies rely on them too heavily, and how these proposed changes could affect future FDA interactions.

Additional topics include:

• MDIC’s best practices for validating medical device cybersecurity through penetration testing

• Updates on FDA's TEMPO pilot and Experiential Learning Program (ELP)

• FDA's increasingly entertaining Instagram food safety campaign

• Early reports on FDA leadership candidates

• Upcoming MedTech conferences and Bluestocking Health's new 2026 conference calendar

As always, the conversation mixes practical regulatory insights with questionable jokes, industry observations, and plenty of side conversations.