Medtronic argued that because the FDA approved the safety and effectiveness of the device under the premarket approval
process, the MDA's preemption provision, [sections] 360k(a), barred her state law claims.
As we work toward completing subject enrollment in the pivotal trial, we expect to receive continuing guidance from the agency on a number of topics, including how test results should be presented to physicians, how to present clinical trial results for review, how to structure the application for premarket approval
and plans for postmarket surveillance.
The panel's recommendation will be considered by the FDA in its review of the Premarket Approval
(PMA) application for the device.
On June 7, 2006, GlucoTec, through its responsible third party official, Underwriter Laboratories Incorporated, received correspondence from the FDA which stated, "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally market predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval
The regulatory approval process for our continuous glucose monitoring systems involves, among other things, successfully completing clinical trials and obtaining a premarket approval
, or PMA, from the FDA.
Potential risks and uncertainties include the uncertainties associated with the prospects for FDA approval of our premarket approval
application for the REVELATION Tx, including the ramifications of our recent meeting with the FDA, the prospect for any future clinical trials or regulatory activities, the Company's ability to obtain funding under the Agility loan facility, the risks associated with the Agility loan facility's restrictive covenants, security interest, fee provisions and other terms and conditions, the risk that the Company will not be able to raise additional capital in the immediate term as needed to continue operations and the risk that we will be unable to secure a strategic transaction involving the Surgical Ablation System.
0 system; those relating to our ability to timely and successfully complete our patient clinical trials; our ability to timely and successfully complete and submit our premarket approval
application to the FDA; the timely and final approval by the FDA of our ComfortScan system as a adjunct to mammography, which approval in the U.