Via DuVal & Associates
The FDA regulatory law firm of DuVal & Associates has been participating in the COVID-19 crisis by helping many companies seek FDA Emergency Use Authorizations (EUAs) for ventilators, cannulas, diagnostics, respirator masks, an abbreviated form of approval. The firm has also worked on many other EUA products ancillary and outside of the core mission of stopping the spread of the COVID-19 particles and helping patients breathe.
The firm has developed an expertise dealing with the FDA on EUAs. It has even provided to FDA suggestions on how to improve FDA’s benefit/risk-based approval criteria on EUAs to facilitate more and quicker authorizations since FDA, although working hard, is lagging behind. FDA has understaffed this function and has been overwhelmed by the number and wide variety of EUAs, but they are improving. We are proud to be part of the evolution of FDA’s thinking on EUAs and to assist so many companies who want to help in this time of need.
“DuVal & Associates, P.A. has been swamped expeditiously assisting companies all over the United States and the rest of the world to seek EUAs from FDA for ventilators, cannulas, respirator masks, diagnostics, and other critical products,” said Mark DuVal. “We are proud to serve this industry and our country and its citizens in this time of the COVID-19 crisis. We thank our team of dedicated regulatory lawyers and biomedical engineers for the pace of their work in response to this crisis.”
MAA COVID-19 INFORMATION DISCLAIMER:
The Medical Alley Association is providing COVID-19 related information, including the “COVID-19 Resource Connect” feature on its website and summaries of laws, executive orders, and government programs that may be of interest to members, as a public service. The Medical Alley Association makes no representations, guarantees, or warranties as to the accuracy, completeness, currency, or suitability of the COVID-19 related information provided by the Medical Alley Association on its website, in newsletters, or in any other communications. The Medical Alley Association specifically disclaims any and all liability for any claims or damages that may result from providing COVID-19 related information online or in other communications or linking to third party websites or other sources of information. The Medical Alley Association makes no effort to independently verify, and does not exert editorial control over, information provided by third parties.
The Medical Alley Association does not endorse any of the products, vendors, consultants, or documentation referenced in, or connected to parties through, the COVID-19 Resource Connect feature or via email or other communications.