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The International Society for Pharmaceutical Engineering (ISPE) has proposed changes to the FDA’s draft guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization (ICH) for makers of drugs and drug-device combination products. Read More
Devices containing cobalt must meet new safety and performance requirements that went into effect Oct. 1 in the European Union, following a four-year review process. Read More
The FDA will enforce standard date formatting and Unique Device Identification (UDI) labeling requirements for certain Class I and unclassified devices starting Sept. 24, 2022, the agency said in a new draft guidance released yesterday. Read More
The COVID-19 pandemic has brought about an “explosion” of interest in consumer diagnostics, but it remains to be seen if the regulatory flexibility the FDA has shown toward those products will continue beyond the public health emergency, a leading healthcare industry attorney says. Read More
The FDA takes on average more than five months (163.4 days) to review devices for 510(k) clearance, according to a law firm’s analysis of almost 12 years’ worth data from the FDA’s Center for Devices and Radiological Health. Read More
In a move that is unlikely to resolve the matter, the company has added a disclaimer on its website stating that the Smart Sock “is an information-gathering product for use with healthy babies only. It is not a medical device.” Read More
Australia’s Therapeutic Goods Administration (TGA) describes how it classifies “active” medical device products in a newly released guidance. Read More
Devicemakers scrambling to classify or reclassify their products under the EU’s Medical Devices Regulation (MDR) now have some help in the form of a new guidance. Read More
The FDA is reclassifying some surgical staplers for internal use from lower-risk Class I devices to higher-risk Class II devices that require premarket reviews. Read More