We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
A new draft guidance issued by Health Canada walks manufacturers through the various requirements of obtaining a license to market a Class II, III or IV medical device. Read More
Manufacturers and assemblers of x-ray computed tomography (CT) equipment may use an alternate measure of the computed tomography dose index (CTDI) when scanning patients, a new FDA guidance says. Read More
The FDA’s Blood Products Advisory Committee will hold a public hearing next month to consider a request by the Naval Medical Research Center to conduct a clinical trial of Biopure’s blood substitute, Hemopure. Read More
The FDA has revised industry guidance on device tracking, noting that manufacturers are not required to track devices unless the agency has issued them an order to do so. Read More
Pending industry user fee reauthorization will strongly shape the FDA’s likely effort to use regulatory action to preempt legislative fixes for a number of issues in the next Congress, sources say.
The FDA has responded to complaints of ambiguity in the pedigree rule by issuing two documents outlining its enforcement priorities and further defining who is covered by the new requirement.