By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting For both drugs and devices, personalized therapies that target specific patient biomarkers and tailor treatments to individual biological needs are the next big thing. Historically, the FDA has opted for device clearances with narrow permutations that don’t differ much between patients. Given […]
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting On July 7, 2026, FDA published a draft commitment letter detailing proposed recommendations for the reauthorization of the Medical Device User Fee Amendments (MDUFA), which govern how medical device manufacturers interact with FDA and fund medical device review in the United States, for fiscal […]
By: Shu Xiang, Mittal Consulting On June 15, 2026, the FDA issued a warning letter to Happiest Baby, Inc., the manufacturer of SNOO Smart Sleeper. For companies that view regulatory as a one-time effort to obtain the FDA’s blessing and then move on, this warning letter is a clear wake-up call. If you’ve been a […]
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting While it may seem surprising, medical devices with the same technological characteristics but different clinical applications sometimes receive different classification from FDA. It all comes back to a device’s benefit-risk framework. The phrase “benefit-risk framework” is often used in medical device regulation […]
By : Elle Winn & Susan Lubejko PhD- Mittal Consulting On Thursday April 23, the United States Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced a new, expedited Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for certain FDA-designated Class II and III Breakthrough Devices. The announcement […]
By: Susan Lubejko PhD, Mittal Consulting The new year has brought big news on the mindset shift that FDA is taking regarding certain AI-powered digital health and wearable wellness products. Following an address to the Consumer Electronics Show in Las Vegas, FDA Commissioner Dr. Marty Makary joined the Fox Business show Varney & Co to […]
By: Anya Bekhtel, Mittal Consulting ‘With this new finalized guidance document, FDA has eliminated the requirement for real world evidence (RWE) supplied in marketing applications to mandatorily include identifiable, individual patient data, opening a host of datasets for use that were previously inadmissible.‘ On Monday December 15, 2025, the FDA announced that the Agency is […]
In hindsight, many of us underestimated just how severe the consequences of the recent FDA shutdown would be. While initial commentary focused on political brinkmanship, the real impact ran much deeper—touching patient safety, innovation pipelines, and the broader medtech ecosystem. Why We Were All Wrong At first, the assumption was that a temporary lapse in […]