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The center has received more submissions for novel devices over the past twelve months than during any 12-month period since the FDA began tracking in 2015. Read More
Pharmaceutical and medical device companies should not be held liable for terrorist actions after providing medical products to the Iraqi government, says an amicus brief from the U.S. Chamber of Commerce and PhRMA filed to the U.S. Supreme Court. Read More
As the 118th Congress continues, FDAnews will track important pending legislation to keep you updated on laws and regulations that could impact your business. Read More
The company says customers should return any inventory that is not implanted and report any adverse reactions or quality problems to Abbott or the FDA. Read More
Only 28 out of 64 medical device and diagnostic technologies, or 44 percent, requiring new Medicare coverage received reimbursement from 2016 to 2019, with the median time to at least nominal coverage taking 5.7 years, according to Stanford University researchers. Read More
Over the past week, the FDA issued final guidance for waivers, exceptions, and exemptions from Section 582 of the FD&C Act, draft guidance for previously approved antiretrovirals for treatment of HIV, and modifications to the list of recognized consensus standards. Read More
CDRH is accepting and holding in-person meetings with stakeholders and also offering hybrid in-person and virtual – meeting options, Director Jeff Shuren said in a statement Wednesday updating the industry on its return to post-COVID normalcy. Read More
Quidel Cardiovascular’s recall of Quidel Triage Cardiac Panels, used to diagnose a heart attack, has been deemed class I by the FDA, the most serious type of recall as use of the device may cause injury or death. Read More
Stryker received an FDA Form 483 after a Jan. 17-24 inspection of its Portage, Mich., plant showed that the company did not have a formal unit to receive, review and evaluate complaints about its C2 Nerve Monitor device. Read More