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Devicemaker Genicon failed to provide adequate resources for quality control operations to ensure that devices were designed and produced according to FDA regulations, according to a 15-item Form 483 the firm received following an inspection of its Winter Park, Florida facility. Read More
Failure to validate the design of its Specboard, which is used to localize suspect breast lesions during surgery, was among the quality system lapses the FDA observed during an inspection of Macbrud’s Miami, Florida facility. Read More
The FDA clarified in new proposed rule how it determines whether products are intended for use as drugs or devices and how it decides if approved products are intended for a new use. Read More
A set of three guidance documents the FDA released Sept. 25 provides a look into the agency’s implementation of its new Accreditation Scheme for Conformity Assessment (ASCA) pilot program for devices. Read More
If an order is finalized, manufacturers that intend to market this type of device would need to apply for a 510(k) clearance prior to marketing it. Read More