News In Brief
This article was originally published in The Gray Sheet
Industry urges restraint at 510(k) modifications meeting. User fee sequestration unaddressed at House Appropriations Committee markup. More news
You may also be interested in...
Ophthalmic Devices Panel Supports Safety For Ocular Therapeutix’ ReSure Sealant, But Other Votes Mixed
The FDA panel voted 9-1 in favor of the safety of Ocular’s PMA Sept. 19, but 5-1 on whether the benefits of the device, an in situ-formed hydrogel that creates an adherent temporary, soft and lubricious sealant to prevent leakage from clear corneal incisions, outweigh its risk, and 5-3 on its effectiveness. Multiple panelists abstained from the last two votes based on concerns with wording of the indication.
Uroplasty names new chief financial officer. Changes in PCORI leadership. TeraRecon appoints new senior VP. Former BD CEO joins Pocared Diagnostics board.
Industry Says Update To 510(k) Modification Policy Should Emphasize Design Controls, Risk Management
As FDA prepares a report due to Congress in January on its policy for determining when a modified device needs a new 510(k), industry representatives say major changes are not necessary to the current process. But they suggest some tweaks that could make things work more smoothly.