The FDA classification underscores the urgency of the situation and the potential danger posed by the contaminated products.
FDA commissioner Marty Makary revealed at the 2026 CES trade show in Las Vegas that low-risk devices will face less ...
Certain people risk severe or life-threatening reactions if they consume these products, according to an official alert.
The U.S. Food and Drug Administration said on Tuesday that it will limit regulation of wearable devices and software designed ...
The U.S. Food and Drug Administration says it will ease regulatory requirements for certain consumer wearable health devices.
Potential blockbusters and root-cause treatments from Eli Lilly, Merck, Takeda and others could get a regulatory nod this ...
FDA feedback supports 505(b)(2) filing in H2 2026; No additional studies required beyond current planned 32-subject clinical ...
Vera Therapeutics received priority review from the FDA for its biologics license application for atacicept to treat adults ...
The US Food and Drug Administration has missed its latest deadline to propose banning formaldehyde and certain ...
The FDA will ease regulation of digital health products, aiming to deregulate AI and promote its widespread use.
FDA nonmedical wearable health data devices providing general health info will not face regulation, clarifying guidance for tech companies and investors.
Johnson & Johnson’s filing comes a month after Medtronic gained U.S. clearance for its Hugo system as competition in the soft ...
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