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 […]
By- Susan Lubejko PhD- Mittal Consulting In March 2025, FDA released two new guidance documents with potentially big implications for the clinical studies conducted by medical device sponsors. Sex-Specific Data in Medical Device Clinical Studies On March 31, 2025, FDA’s Center for Devices and Radiological Health (CDRH) released its final guidance document Evaluation of Sex-Specific […]
by: Shu Xiang, Mittal Consulting On September 12, 2024, the FDA cleared the Hearing Aid Feature of Apple’s AirPod Pro, which marks another win for the tech giant’s move towards the healthcare arena. This was not the first Apple device feature to receive FDA clearance. In 2018, FDA cleared the ECG App on Apple Watch, […]
By Elle Winn, Mittal Consulting On August 22, 2024, the FDA released a new draft guidance discussing Predetermined Change Control Plans for Medical Devices. Predetermined change control plans (PCCPs) are FDA-authorized plans to implement changes to a medical device at a later point that are included in and approved in a marketing submission to the […]
This draft guidance outlines FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by describing FDA’s expectations for the reviews of 510(k) submissions and EUA requests by third party review organizations. This draft guidance provides updated recommendations on the 510(k) Third […]
