Home > Press > Emergency Filtration Products Issues FDA Update
Emergency Filtration Products, Inc. (EFP) (PINKSHEETS: EMFP) today announced that it has withdrawn the Company's 510(k) notification (510(k)) for its NanoMask product from current FDA review. EFP originally filed its initial 510(k) in 2006. The FDA review had been suspended pending EFP response to various FDA requests for additional information, some of which required the company to commission additional scientific testing. The deadline for responding to the FDA requests is October 5, 2007. However, EFP learned recently that the required testing will not be completed by that time.
Emergency Filtration Products Issues FDA Update
LAS VEGAS, NV | Posted on September 28th, 2007
EFP management believes that the company has made substantial progress in 2007 toward completing all of the additional scientific testing necessary to respond to the FDA information request. EFP in conjunction with Applied Nanoscience Inc. (ANI) (PINKSHEETS: APNN), the company with which EFP has announced a merger, has initiated all required testing and analyses. EFP has also retained well-known scientific and medical experts to ensure thorough scientific response to the FDA's information request. ANI has been assisting the funding of the ongoing testing and expects to continue to assist funding EFP to enable EFP to finalize the required testing in order to resubmit a 510(k) notification.
EFP intends to submit a new 510(k) notification as soon as the company is satisfied that all of the information requested by FDA staff is available and is scientifically sound. The schedule for completion of all required testing and preparation of a new FDA notification is imprecise due to the nature of the testing required. However, management currently estimates that a complete new 510(k) notification will be ready for submission to FDA around the middle of December.
"EFP's initial 510(k) submission to the FDA, which was made by the Company's former management, gave rise to significant comments by the FDA," said Philip Dascher, CEO, EFP. "As a result, EFP, in tandem with ANI, had to develop new testing protocols and perform testing at independent laboratories in order to satisfactorily answer the FDA's comments. Since we are braving new ground, working with emerging technologies, we have had to originate new ways of testing our product -- which have been reviewed by the FDA -- in order to verify its safety and effectiveness. This process has taken considerably more time than originally anticipated, but we expect to complete our testing and file a new 510(k) with the FDA before the end of the year if possible. Obviously, we want to complete the current testing and file our new FDA notification as soon as we possibly can. However, we will not rush this filing or the underlying scientific testing and analyses. We will file again with FDA just as soon as we are confident that we can provide all of the information they requested with a first-rate scientific basis."
About Emergency Filtration Products, Inc.
EFP was formed to develop a preeminent filtration technology that would serve to ensure the safety of rescuers by virtually eliminating risk of cross-contamination during CPR. Our goal was to elevate the confidence of caregivers to the point where fear of exposure to contagious disease would not cause even a moment's hesitation.
For more information, please click here
Emergency Filtration Products
1111 Grier Drive
Suite B Las Vegas NV 89119
1111 Grier Drive
Las Vegas NV 89119
Copyright © Market Wire
If you have a comment, please Contact
Issuers of news releases, not 7th Wave, Inc. or Nanotechnology Now, are solely responsible for the accuracy of the content.
Shaping the Future of Nanocrystals: Berkeley Lab Researchers Obtain First Direct Observation of Facet Formation in Nanocubes August 21st, 2014
Success in Intracellular Imaging of Cesium Distribution in Plants Used for Cesium Absorption August 19th, 2014
Electrical engineers take major step toward photonic circuits: Team invents non-metallic metamaterial that enables them to 'compress' and contain light August 19th, 2014
Promising Ferroelectric Materials Suffer From Unexpected Electric Polarizations: Brookhaven Lab scientists find surprising locked charge polarizations that impede performance in next-gen materials that could otherwise revolutionize data-driven devices August 18th, 2014
Tissue regeneration using anti-inflammatory nanomolecules August 22nd, 2014
A breakthrough in imaging gold nanoparticles to atomic resolution by electron microscopy August 22nd, 2014
Malvern’s Dr Alan Rawle talks TLAs in plenary lecture at Particulate Systems Analysis conference August 21st, 2014
Water window imaging opportunity: A new theoretical study elucidates mechanisms that could help in producing coherent radiations, ultimately promoting high-contrast imaging of biological samples August 21st, 2014