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The White House Office of Management and Budget (OMB) signed off late last week on the FDA’s proposed rule to harmonize its Quality System Regulation (QSR) with the International Organization for Standardization (ISO) 13485. Read More
The EU and its member states must take urgent action to increase the number of notified bodies authorized to certify devices under the EU’s In Vitro Diagnostic Medical Devices Regulation (IVDR) that goes into effect May 26. Read More
The FDA would be able to use outside evaluators to speed authorizations of in vitro diagnostic tests needed to identify the pathogens causing future pandemics if a bill pending in the Senate is enacted into law. Read More
A group of drug and device companies is asking the U.S. Court of Appeals for the D.C. Circuit to toss out its recent decision to revive a lawsuit in which plaintiffs are seeking to hold the companies liable for aiding in the funding of acts of terror in Iraq. Read More
The FDA has issued final orders classifying four medical devices as Class II (special controls), and said the classification will help increase patient access to the devices. Read More
In an effort to better understand high prices for drugs and diagnostics, prominent doctors groups and other advocacy groups have called on the Biden administration to openly share the costs of clinical trials paid for by the federal government. Read More
The FDA needs to work with the Federal Trade Commission (FTC) and other federal agencies to improve its regulation of at-home diagnostics, which are not clearly distinguished from relatively unregulated “general wellness products,” according to an opinion piece by three bioethicists in the Journal of the American Medical Association. Read More
The Center for Devices and Radiological Health (CDRH) has set aggressive goals to measure its success over the next few years in a “strategic priorities” report released yesterday. Read More
Becton Dickinson (BD) has completed its purchase of Cytognos, a privately held Spanish company that specializes in flow cytometry products for blood cancers. Read More
Senators and members of the House of Representatives from both political parties have asked the FDA to explain the holdup in submitting the commitment letter that the agency negotiates with the industry ahead of reauthorization of the Medical Device User Fee Act (MDUFA). Read More
New guidance from the European Union on implementing the In Vitro Diagnostics Regulation (IVDR) emphasizes that regulators will expect to see continuous evidence of a diagnostic product’s safety throughout its entire lifecycle. Read More