CBS News, December 20, 2023: CBS News article dives into the lack of FDA oversight within the medical device industry. Increased patient harm is exposed in lawsuits and records.
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Patient, Consumer, and Public Health Coalition Letter to Congresswoman Dingell Thanking Her for Requesting a GAO Report on Post-market Surveillance of Medical Devices
June 7, 2022: We write to express our gratitude as you work to protect patients by promoting post-market review of approved medical devices. Specifically, we greatly appreciate and value your leadership requesting that the Government Accountability Office (GAO) evaluate the current landscape of post-market surveillance of medical devices.
Read More »NCHR Comments on Quality System Regulation Amendments for Medical Devices
May 24, 2022. We recognize that the proposed harmonization with international consensus standard for devices would allow companies to have a single quality management system. However, the proposal ignores several issues of great importance to patients and consumers, and these issues deserve more attention as FDA considers changes to the proposed rule.
Read More »Wearable Health Devices and Personal Health Trackers: What You Need to Know
Wearable medical devices such as the FitBit or other SmartWatches are electronic devices that you wear to track personal health data, such as how many steps you have taken today or your heart rate. We explain how wearable devices are regulated, are they accurate, and what are the risks of relying on them?
Read More »NCHR’s Comments to FDA on the Remanufacturing of Medical Devices
September 22, 2021: We agree with the FDA that clarification is needed of whether or not activities performed on medical devices are considered “remanufacturing” or “servicing,” and we support the draft guidance’s clarity on how to correctly classify a procedure.
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