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26 Aug

FDA Update: Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers

Protective Barrier Enclosures Without Negative Pressure Used During the COVID-19 Pandemic May Increase Risk to Patients and Health Care Providers As the FDA learns more about what is effective and what isn’t or possibly harmful for the treatment of COVID-19, they make adjustments. Here is an EUA that they issued for a medical device back

17 Aug

FDA Update: FDA Expands Hand Sanitizer Warnings to include 1-propanol Contamination

The FDA is warning consumers about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol. After testing, they have proven to be contaminated with 1-propanol contamination. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is a toxic and

16 Aug

LIFE after the EUA

By Alan Schwartz YES, there will be a day when the US EUA, Emergency Use Authorization Act, will be lifted, the medical device industry goes back to reality and the FDA regains control of the medical approval process with the “a REAL” device review in place. In my almost 5 decades of FDA experience, this

27 Jul

FDA Regulatory Strategy

FDA Regulation of Artificial Intelligence/ Machine Learning in Medical Devices Introduction The use of Artificial Intelligence/ Machine Learning (AI/ML) will revolutionize medical devices by making them more efficient and improving their performance. AI/ ML can be defined as “techniques used to design and train software algorithms to learn from and act on data received from

22 Jul

What is the Best Price for Your Medical Device?

How do manufacturers of a new medical devices determine what is the best price for their product? The typical method is to look for similar products in the marketplace and arrive at a price which will be competitive. However, there are certain circumstances that will allow you to set a higher price based on what

15 Jul

FDA MedWatch Alert: Hand Sanitizers by 4e Brands North America

FDA MedWatch Alert – July 14, 2020 Hand Sanitizers by 4e Brands North America: Recall Due to Potential Presence of Undeclared Methanol (Wood Alcohol) The company 4e Brands North America, based out of San Antonio, Texas, issued a nationwide voluntary recall of hand sanitizer due to the potential presence of undeclared methanol (wood alcohol) on

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