How do I get a product approved by the FDA? The Food and Drug Administration's regulatory approaches to marketing approval of the products it regulates are as differed as the products themselves. These difficulties are mandated by the acts FDA enforces and the relative pitfalls that the products pose to consumers. FDA reviews the results of laboratory, animal and human clinical testing done by companies to settle if the product they want to put on the request is secure and operative. FDA doesn't develop or test products itself. The Agency does thispre-market review for new human drugs and biologics (similar as vaccines, blood products, biotechnology products and gene curative), complex medical devices, food and color complements, infant formulas, and animal drugs. FDA has streamlined its review process for medical products in recent times to help speed important new treatments to cases. IZiel one of the USFDA Consulting Firms implements an Outcome-Based Delivery Model to provide complete solution from developing engineering documentation to receiving USFDA Approvals & establishment registrations thereafter. Our teams from USA & India collaborate to develop a CostEffective Model to complete USFDA Approvals for customers in USA, Europe, and Asia.
Upon completion of Engineering & QMS Documentation, the regulatory team of IZiel who is one of the USFDA Consulting Firms conducts the predicate device search, comparative analysis and ensure all the necessary standards are complied with. Thereafter, IZiel team initiate the writing of 510(k) / PMA, which is verified and approved by our US Regulatory Consultants. Our highly experienced US regulatory consultants include Ex-FDA Auditors, have conducted 3500 + reviews and approvals and have experience with Class I, II & III devices in Cardiology, Neurology, Image Diagnostics and Orthopaedic products.