NTAP/TPT Alternative Reimbursement Pathway Repealed for Breakthrough Devices – A Blow to Medical Device Innovation
By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting On Tuesday August 4, the Centers for Medicare & Medicaid Services (CMS) finalized the repeal of the alternative pathway for FDA-designated Breakthrough Devices to...
Wave Neuro Introduces Individualized TMS Therapy for PTSD Using an Unconventional 510(k) Approach
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....
MDUFA VI (FY 2028-2032) Newly Proposed FDA Pre-Submission Fee
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),...
It is a Marathon, not a Sprint: Lessons from SNOO’s FDA Warning Letter
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...