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The FDA announced in a new guidance that it does not plan to object to delays in adverse event reporting for medical products during the pandemic. Read More
The European Commission is seeking to push back the implementation date of the Medical Device Regulation (MDR) by one year as COVID-19 wreaks havoc globally. Read More
Under a settlement with the Federal Trade Commission, devicemaker NeuroMetrix has agreed to pay at least $4 million and to stop making deceptive claims that its Quell transcutaneous electrical nerve stimulation device treats pain throughout the body when placed below the knee. Read More
The FDA released final guidance detailing how the agency approves third-party review organizations and which devices are eligible for third-party evaluations. Read More