Japan has the "slowest, least transparent and most difficult regulatory system" of the major medical device markets, hurting developers of innovative, advanced-technology devices, a new report from the International Trade Commission (ITC) says.
New guidance documents prepared by three study groups of the Global Harmonization Task Force (GHTF) should help smooth the way for more expedited device approvals and ease firms' ability to comply with foreign regulations.
Corin has overcome several obstacles -- including patients refusing to participate in the control arm of a clinical study testing its joint device -- to gain a favorable FDA advisory committee panel vote of 41 recommending that the agency allow the firm to market its device.
Splintek, a division of Power Products, must stop marketing its Sleep Right adjustable night guard for OTC purchase because the company did not gain premarket approval to sell the device without a prescription, an FDA warning letter said.
A newly published survey suggests orthopedists want to see a shorter device approval process at the FDA as well as changes to existing laws to make unapproved products more easily available to consumers.
An FDA advisory panel was unable to give its vote of confidence to a new device meant to treat severe depression last month. This leaves Cyberonics’ vagus nerve stimulation (VNS) therapy to dominate the U.S. market for emerging alternative treatments to currently accepted electroconvulsive therapy (ECT), an analyst says
Clinical trial results for a heart device may be biased and new randomized clinical trials will be needed to improve the device's chances for FDA approval, agency officials said at an FDA panel meeting last week.
The U.S. and Japan want to remove barriers to timely medical device approvals through the “Harmonization by Doing” (HBD) initiative, aimed at developing common protocols for premarket clinical studies of new cardiovascular technologies. Read More
The U.S. and Japan want to remove barriers to timely medical device approvals through the "Harmonization by Doing" (HBD) initiative, aimed at developing common protocols for premarket clinical studies of new cardiovascular technologies. Read More