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The FDA published a notice in the Oct. 26 Federal Register to announced the Dental Products Panel of its Medical Devices Advisory Committee will meet Nov. 9.
While devicemakers at last week's Transcatheter Cardiovascular Therapeutics (TCT) conference presented clinical trial results in an effort to downplay the risk of clotting from the use of drug-eluting stents, analysts said the results of the trials are inconclusive.
Nanotechnology should be approached in a spirit of international collaboration and, as a part of this global picture, industry must be part of the solution in regulating nanotechnology, said Philippe Martin, directorate-general of the European Commission's (EC) Health and Consumer Protection branch and a principal administrator for the EC's nanotechnology policy and development efforts.
The FDA issued a draft guidance with recommendations on the level of detail needed to fulfill additional requirements for premarket approval (PMA) application annual reports.
Thermoplastic Comfort Systems' dental repair devices are adulterated due to violations of current good manufacturing practice requirements, a recent FDA warning letter said.
Given Imaging, based in Israel, announced Oct. 23 it filed claims of patent infringement against Olympus and its subsidiaries Olympus Medical Systems and Olympus America.
Until more information is known about the exact health risks presented by nanotechnology, the federal government needs to use a sliding scale to determine potential harm, a former federal official says.
The FDA has not changed its inspection policies in the deviceprogram area, despite a court ruling last year that favored devicemaker Utah Medical in its challenge of those policies, agency spokeswoman Heidi Valetkevitchsaid.
The FDA Alliance, a coalition of former agency officials, activists, industry associations and companies, has hired the law firm Patton Boggs to help the group advocate for increased FDA appropriations.