Here’s What the FDA Label on Your Personal Care Products Means
Many consumer devices undergo the FDA clearance process, such as LED masks and fitness trackers that have features like irregular heart rhythm or sleep apnea alerts. They are usually labeled as such.
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Nearly a third of FDA medical device adverse event reports filed late
A study has found that nearly a third of medical device AEs were reported by manufacturers later than FDA's required 30-day ...
Modern Healthcare14d
Medical device recalls hit a four-year high in 2024. Here’s why
There were 1,048 medical device recalls in 2024, an increase of almost 25% from the 840 recalls that occurred in 2023, ...
Modern Healthcare8d
FDA labels Philips' recall of Tack Endovascular Systems a Class I
Complications with the implant used to treat blood vessel dissection after balloon angioplasty or stent placement can result ...
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FDA goes digital with eServices Portal System
THE Food and Drug Administration (FDA) has launched an online application process for Certificate of Medical Device Notification (CMDN) for Class A ...
More than 1.2 million medical device side-effect reports not submitted within legal timeframe, analysis finds
More than 1.2 million medical device adverse event reports were not submitted to the US Food and Drug Administration (FDA) ...
Medical Device Network on MSN9d
Philips pulls endovascular implant from market after FDA Class I recall tag
Philips will no longer sell its Tack endovascular system in the US following a Class I recall by the US Food and Drug ...