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By Elle Winn, Mittal Consulting On August 22, 2024, the FDA released a new draft guidance discussing Predetermined Change Control Plans for Medical Devices.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This draft guidance outlines FDA’s current thinking on key aspects of the 510(k) Third Party Review Program and third party review of Emergency Use Authorization (EUA) requests by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 This draft guidance provides updated recommendations on the 510(k) Third […]
We are ecstatic to welcome our newest team members in the new year 2024! With valuable expertise and unparalleled ambition, our new hires are ready to expand Mittal Consulting services globally! Welcome Shu Xiang, Elle Winn, Shambhavi Sharma!