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The FDA issued a final rule Aug. 23 amending the classification of noble and base metal alloys used in dental work to exempt them from premarket notification requirements.
Devicemakers looking to maximize reimbursement for their products should focus on taking a team-oriented approach to the reimbursement process, according to reimbursement and development experts.
The FDA has ordered a Colorado light therapy firm to immediately remove a series of misleading ads and promotional materials that market its products for unapproved indications and use a false FDA letter to confirm its therapeutic claims.
The FDA has released a new guidance updating industry on the effect various review actions have on Medical Device User Fee Modernization Act (MDUFMA) time goals during the premarket 510(k) submission process.
The FDA issued a final rule May 10 designating the immunomagnetic circulating cancer cell (CCC) selection and enumeration system as a Class II device with special controls.
While it’s still too early to tell what regulatory course Daniel Shultz will take in his tenure as acting chief of the FDA’s Center for Devices and Radiological Health (CDRH), he told D&DL last week that he doesn’t plan to stray far from the path that his predecessor, David Feigal, blazed.
The future of the FDA’s Center for Devices and Radiological Health (CDRH) will be focused on meeting the goals established by the Medical Device User Fee and Modernization Act (MDUFAMA), said the center’s new acting director Dan Schultz
The FDA has added three new single-use devices (SUDs) to the list of reprocessed SUDs requiring premarket clearance, a move that will force reprocessors of these devices to submit 510(k) clearance data by July 13, 2005, to continue marketing their products.
Devicemakers should consider risk management over the total product life cycle using a top-down approach, FDA staffers and industry experts said last week at the Association for the Advancement of Medical Instrumentation/FDA international conference on medical device standards and regulations.