February 17, 2021. There is no reasonable assurance that the Lutonix 014DCB device is effective and therefore no reasonable assurance that the benefits outweigh the risks.
Read More »Tag: medical devices
Patient Safety Advocate Raises Alarm Over HHS/FDA Push That Could Exempt 80+ Devices From Regulation
MedTech Insight: January 19, 2021. HHS plans to waive regulatory review of more than 80 different types of medical devices granted, but advocates have concerns.
Read More »New Trump Administration Policies for FDA Under Fire
Medscape, January 15, 2021. New policies will weaken regulations on medical products if the Trump administration passes them before leaving.
Read More »NCHR Statement at FDA Medical Devices Advisory Committee Meeting on the VisAbility Micro Insert
November 9, 2020. The risks for this device are notable, especially considering that it is unnecessary because other, non-invasive and approved treatments are available.
Read More »Hahn Says FDA Wants Higher Device User Fees
Politico Pro, October 27, 2020. FDA to raise user fees for medical device makers, but experts caution against relying too heavily on them.
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