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- Anya Bekhtel (Mittal Consulting) Artificial intelligence and machine learning are driving innovation throughout healthcare, creating opportunities for faster and more accessible treatment solutions. While the FDA has authorized hundreds of AI and ML enabled devices over the last five years, the pathway to reimbursement for these systems has remained unclear. The Senate Artificial Intelligence […]
WHAT : Medtech World Bay Area Event WHERE : Signia Hotel by Hilton, San Jose 170 S Market St, San Jose, CA 95113 WHEN: June 27th, 2025 MedTech World Bay Area 2025 is just around the corner, and as the premiere regulatory affairs partner for startups in the medical device industry — and a […]
By- Elle Winn (Mittal Consulting) FDA Revamps Q-Sub Process with New Guidance and Digital Submission Template On May 29, 2025, the U.S. Food and Drug Administration (FDA) released two significant guidances related to the Q-Submission (Q-Sub) Program for medical devices. These include the finalized guidance, “Requests for Feedback and Meetings for Medical Device Submissions: The […]
May 14, 2025 Since 2021, Siloam Vision has been pioneering clinical solutions to prevent blindness and improve global vision health. Retinopathy of Prematurity (ROP) is a leading global cause of permanent infant blindness, particularly in regions with limited access to adequate eye care. Driven by the belief that no child should lose their sight to […]
By- Elle Winn (Mittal Consulting) It is no secret that the new administrations pivot to an aggressive tariff strategy, including a 145% duty on goods from China and 10% baseline tariff for most other countries, has created a higher-stakes environment for the U.S. med-tech space. While for larger established companies, this means some cost pivots […]