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FDA Nails Surgical Staplers With Stronger Regulation

Reclassification to higher risk category was years in the making

William-maisel , Office-of-product-evaluation , Radiological-health , Letter-to-health-care-providers , Product-evaluation , Health-care ,

Restless Sleep: Recall Impacts Millions of Sleep Apnea Patients Worldwide

Restless Sleep: Recall Impacts Millions of Sleep Apnea Patients Worldwide
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Restless Sleep: Recall Impacts Millions of Sleep Apnea Patients Worldwide

Restless Sleep: Recall Impacts Millions of Sleep Apnea Patients Worldwide
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AGG Food & Drug Newsletter - June 2021 | Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - June 2021 | Arnall Golden Gregory LLP
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Sooner or Later, Everything Old is New Again: FDA Issues Draft Guidance Addressing Remanufacturing of Medical Devices | Arnall Golden Gregory LLP

Sooner or Later, Everything Old is New Again: FDA Issues Draft Guidance Addressing Remanufacturing of Medical Devices | Arnall Golden Gregory LLP
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The major health care and cybersecurity risk of 'Right-to-Repair' laws

The major health care and cybersecurity risk of 'Right-to-Repair' laws
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William-maisel , Office-of-product-evaluation , Radiological-health , Product-evaluation , Good-manufacturing , Automated-external-defibrillators , Cybersecurity-practices-associated , Servicing-medical-devices , வில்லியம்-மைசேல் , அலுவலகம்-ஆஃப்-ப்ராடக்ட்-மதிப்பீடு , கதிரியக்கவியல்-ஆரோக்கியம் , ப்ராடக்ட்-மதிப்பீடு

FDA Suspends Review for Non-COVID-19 In Vitro Diagnostics (IVD) Submissions and Expects Review Delays in Non-IVD Products | Womble Bond Dickinson

[author: Heather Hatcher, Ph.D.]
A year into the current public health emergency, the FDA’s Center for Devices and Radiological Health (CDRH) announced on Thursday, April 15, 2021, that the center is “prioritizing and triaging our work using existing resources in order to focus on our COVID-19 response, resulting in delays in some other work areas.” Dr. Jeff Shuren, Director, CDRH, and Dr. William Maisel, Director, Office of Product Evaluation and Quality at CDRH, reported that the astounding numbers of pre-EUA and EUA submissions received for COVID-19 tests and collection kits created a significant workload that has strained the center’s resources in the review of in vitro diagnostic (IVD) files. Shuren and Maisel report that current pre-EUA and EUA submissions under active review across the center exceeds 600 with an average receipt of more than 40 new pre-EUA and EUA submissions per week in addition to non-COVID-related submissions. Every office in CDRH has been heavily impacted and staff and resources have been reallocated from product areas less impacted to those with increased submission volume. CDRH staff have been working nights and weekends, and Congress has approved one-time funding support to hire temporary employees and use third party reviewers.

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Review for Non-COVID-19 In Vitro Diagnostics Suspended

Review for Non-COVID-19 In Vitro Diagnostics Suspended
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FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale

FDA Alerts Public about Improper Use of Thermal Imaging Devices; Warns Firms for Illegally Offering Thermal Imaging Systems for Sale
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SILVER SPRING, Md., March 4, 2021 /PRNewswire/ -- The U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature—also known as telethermographic systems, infrared thermographs, thermal cameras, and "fever cameras"—that improper use of the systems may provide inaccurate temperature readings due to a variety of factors. Additionally, the FDA issued several Warning Letters to certain firms offering unapproved, uncleared, and unauthorized thermal imaging systems for sale.

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FDA alerts consumers about improper use of thermal imaging systems, warns firms for marketing unapproved devices

FDA alerts consumers about improper use of thermal imaging systems, warns firms for marketing unapproved devices
The U.S. Food and Drug Administration today alerted consumers, health care providers and other users of thermal imaging systems intended to measure human body temperature—also known as telethermographic systems, infrared thermographs, thermal cameras, and "fever cameras"—that improper use of the systems may provide inaccurate temperature readings due to a variety of factors.
Additionally, the FDA issued several Warning Letters to certain firms offering unapproved, uncleared, and unauthorized thermal imaging systems for sale.
While thermal imaging is not an effective diagnostic device for COVID-19, it can determine if someone has an elevated temperature, which can be an important risk management tool during the pandemic when used properly."

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