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Recent Posts
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Category Archives: FDA
Cracking the Code: How to Survive the FDA’s AI-Enabled Medical Device Guidance and Maintain Your Sanity
Buckle up, folks—our favorite regulatory sheriffs at the FDA have dropped another massive rulebook, this time titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” If you’re still awake after reading that title, congratulations! This document is … Continue reading
Posted in FDA
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Embracing AI in Healthcare: The FDA’s Guidance on Good Machine Learning Practice
Embracing the Future: The FDA’s Guidance on AI in Medical Devices As we enter an exciting era of technological advancement, the role of artificial intelligence (AI) in medical devices stands out as particularly transformative. The FDA’s recent guidance on “Good … Continue reading
Posted in EN 60601-1, FDA, Medical Devices Regulation (EU)2017/745
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The FDA and Common Electromagnetic (EM) Emitters – What You Need to Know
The FDA, per their Guidance Document published June 6, 2022, requires that medical device manufacturers be able to show that their product is immune to common Electromagnetic (EM) Emitters, such as RFID Readers, Near-field Communication (NFC) systems, metal detectors, Electronic … Continue reading
Posted in FDA, Product Testing
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Easy Approach to Essential Performance in Medical Devices for FDA
F2 Labs has many conversations every week with medical device manufacturers who are struggling to define Essential Performance for their device. From our experience, the confusion around Essential Performance frequently stems from the fact that what a device manufacturer views … Continue reading
Posted in FDA
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FDA Advises Medical Device Manufacturers to be Vigilant and Validate Data
The U.S. Food and Drug Administration recently sent out an Open Letter to Industry to remind manufacturers of medical devices that they should always be vigilant in verifying the accuracy of third party testing data that they are using for … Continue reading
Posted in FCC, FDA, Product Testing
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Pacemakers and Electric Cars
Over the past decade, we have seen an explosion of popularity with various green technologies, and at the forefront of that are electric vehicles and the charging stations that keep them going. A new study questioned whether individuals who wear … Continue reading
Posted in CE marking, Consulting, EMC Directive 2014/30/EU, EMC Testing, FCC, FDA, Radio Equipment Directive 2014/53/EU
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What Now?
A comprehensive guide into the listing standards that are required after testing to compliance marks. Continue reading
Posted in ATEX Directive 2014/34/EU, CE marking, EMC Directive 2014/30/EU, FCC, FDA, Field Label, GPSR, GPSR (EU)2023/988, International Testing, Low Voltage Directive 2014/35/EU, Machinery Directive 2006/42/EC, Machinery Regulation (EU)2023/1230, Medical Devices Regulation (EU)2017/745, PPE Regulation (EU) 2016/425, Pressure Equipment Directive 2014/68/EU, Prop 65, Radio Equipment Directive 2014/53/EU, REACH, RoHS Directive 2011/65/EU, SPE-1000, UKCA, US Field Label
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F2 Labs’ is Officially Approved as an FDA ASCA-Accredited Testing Lab!
F2 Labs is officially an ASCA-accredited testing laboratory! We are one of only 17 labs approved by the FDA. This program will help increase product safety for the end-user and shorten the time it takes for FDA approval of your product. Continue reading
Posted in ASCA Program
Tagged accreditation, ASCA, compliance testing, FDA, safety testing
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The FDA’s ASCA Program and What it Means
This is the first time in history that the FDA has had a list of approved labs. F2 Labs is officially an ASCA-accredited testing laboratory. Continue reading
Posted in ASCA Program, FCC, FDA
Tagged ASCA, FDA, Medical Device, medical device testing
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FDA approval for a Respiratory Monitor used in COVID19 Treatment – Tested at F2 Labs
It is safe to say that COVID-19 has affected everyone in the world. F2 Labs immediately joined the fight and offered pro-bono services to our customers who are working to alleviate the suffering caused by this terrible illness. “It was … Continue reading
Posted in FDA, Product Testing
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