The Ultimate Guide to hiring a professional FDA Emergency Use Authorization EUA and 510k Consultant

1. The Ultimate Guide to hiring a professional FDA EmergencyUseAuthorizationEUAand510kConsultant UndertheFederalFood,Drug,andCosmeticAct(FD&CAct),theU.S.FoodandDrug Administrationauthorizedtheemergency useofcertainhealthproductsundercertain circumstances.OurFDAEmergencyUseAuthorizationEUAconsultantis authorized to assistinemergency preparedness and response, including the development and delivery of new or unapproved medical products (drugs, biologics, and medical devices) for use in emergency situations. The Thomas Regulatory Resolution Team supports EUA applications and strategies with a solid understanding of FDA requirements for EUA related to COVID-19; we continue to keep up with changing requirements as they evolve during this emergency due to the current global corona viruspandemic.Fromprovidingstrategicroadmapsfornavigatingdifferent EUAsfor COVID-19 products to developing commercial use plans for products available under the EUA, the Regulatory Resolutions of Thomas can advise clients on how to achieve their specific short- andlong-termgoals toensurethey arein linewithFDArequirementsand guidelines.

2. How can we increase your odds of a successfulFDAEUAsubmission? To take advantage of medical device consulting companies, you should place them on the bottom tier of your assembly, as this will help you ensure that they know all the components of the equipment items you provide and can give you suitable advice give you the survivability and consistencyyoucanface.MakingsureyouarereadytosubmityourEUAapplicationis essential, otherwise, you will lose valuable time. The FDA is very sensitive to EUA submissions, butit certainly doesn't want to approve products under study, doesn't have time for lengthy exploratoryconferencecalls,andFDAhasnopatienceforrequestsforincompletesubmission. Theywantstrongsubmissionsforrelativelymatureproductsthathaveprovensafetydataandare inadvancedefficacy testing.TheThomasRegulationResolutionFDAEmergency Use Authorization EUA consultant can help ensure that your application is ready for FDA review. In some cases, the FDA will ask you to participate in a pre-EUA submission to discuss specific itemsrelatedtoproducttesting and clinical expectations. Pre-EUA is the first step towards continuousinteractiveapplicationleadingtoEUA.Wecanalsohelpyouthroughthisprocess. Howdoesour510kConsultantwork? Failure to follow FDA regulations can have costly consequences, so it's important to understand how to effectively communicate with them. Thomas Regulatory Resolution 510k Consultants can help you navigate FDA regulatory requirements to bring your device to market. The FDA 510k process is the means by which medical device manufacturers can demonstrate that their device is an equivalent device in terms of safety and effectiveness. If you're a manufacturer or specdeveloperandyouhaveanewmedicaldevicethatneedspre-marketapproval,you'llneedto submita 510k application.

3. Wehelp customers prepare and submit 510,000 faster with less chance of receiving an initial “RejectAcceptance”(RTA)requestor“AdditionalInformation”(AI)requestfromtheFDA.Our $510,000 consultant is a pre-marketing submission to the FDA to demonstrate that a marketed deviceissafeandeffective, whichisessentiallyequivalenttoadeviceapprovedlegally marketed(21CFR807.92(a)(3))isnotsubjecttopriormarketingapproval.Significant equivalence criteria are set forth in 21 CFR 807.87 and 807.81. We have an entire section at Thomas Regulatory Resolutions dedicated to assisting you in the FDA 510k approval process. Our510kConsultantsexpertswillhelpyoudetermineifyourproductrequiresa510k authorizationand if so,they will guideyou through theprocess.