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Some individuals “may be predisposed to develop a local or systemic immune or inflammatory reaction when exposed to certain metals contained in select implantable devices,” the agency said. Read More
An accredited testing lab may conduct testing to determine conformance of a device with at least one of the standards eligible for inclusion in the ASCA pilot. Read More
The FDA has set out a framework how devicemakers will be able to demonstrate products are as safe and effective as a predicate device under an expansion of the agency’s abbreviated 510(k) pathway for certain, well understood device types. Read More