In October 2025, the FDA issued a safety communication warning that serious complications had been reported with certain uses of radiofrequency (RF) microneedling devices. Nearly a year later, the warning is still shaping how the aesthetics and skincare industry talks about these treatments — and it's worth understanding exactly what it says, and what it doesn't. What RF Microneedling Actually Is RF microneedling combines traditional microneedling — tiny needles that create controlled...

The FDA has published its Medical Device User Fee Amendments, or MDUFA, fee schedule for Fiscal Year 2027. The new fees will apply from October 1, 2026, through September 30, 2027. Medical device manufacturers planning submissions during this period should update their regulatory budgets and submission timelines accordingly. FY2027 Annual Establishment Registration Fee The Annual Establishment Registration Fee for FY2027 is: $13,785 Most medical device establishments required to register with...

The U.S. Food and Drug Administration (FDA) recently announced the first participant selected for its Technology-Enabled Meaningful Patient Outcomes (TEMPO) pilot program, an initiative that could significantly influence how digital health technologies are evaluated and introduced into clinical practice. Rather than representing a new device approval, the announcement reflects a broader evolution in regulatory thinking—one that recognizes the unique nature of software-driven healthcare...