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Potential device issues include diminished battery life, overheating, connectivity issues with the device’s smartphone app and leakage of corrosive chemicals. Read More
The National Association of Manufacturers (NAM) and the Washington Legal Foundation (WLF) have entered the “right to repair” legal fray, questioning the Library of Congress’s (LOC) ability to grant copyright exemptions to third-party repair companies without the opportunity for judicial review. Read More
Upcoming events in the coming weeks include five FDA advisory committee meetings as well as webinars on subjects ranging from GxP system verification and FDA’s sterilization pilot. Read More
Medical device companies that participate in the program can engage and collaborate with solutions providers and the FDA to demonstrate advanced technologies. Read More
An FDA final guidance on premarket submissions for device software functions recommends a risk-based approach to help determine whether the sponsor should submit basic or enhanced documentation to explain its use of new data processing methods. Read More
The recall of Walnut Wearable smart thermometer, a device that continuously monitors body temperature of infants and children up to 6 years, is now deemed FDA Class I, the most serious type of recall as use of the device may cause serious injuries or death. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on regulations that could impact your business. Read More
The FDA said this test is an example of the agency’s continued work with test developers that want to market their products beyond emergency use authorities. Read More
Medical devices continue to take advantage of the technological advances we see in every part of our lives, from phones to virtual reality headsets, with several new devices seeing FDA clearances in the past few weeks. Read More
Over the past week, the FDA issued final guidances on nonclinical evaluation of the immunotoxic potential of pharmaceuticals, drug-drug interaction assessment for therapeutic proteins and cover letter attachments for controlled correspondence and draft guidances on interstitial cystitis/bladder pain syndrome and ICH E6(R3) guideline for good clinical practice. Read More