The Food and Drug Administration\’s (FDA) Center for Drug Evaluation and Research Small Business and Industry Assistance (CDER SBIA), and Center for Devices and Radiological Health (CDRH) Division of Industry and Consumer Education (DICE) are pleased to announce a co-sponsored event developed just for you the Regulatory Education for Industry conference.
The Regulatory Education for Industry (REdI) Conference is an FDA-led forum that brings together the regulatory educators from FDA’s CDER and CDRH.
The Registration is to be done to attend this conference on Regulatory Education for Industry (REdI) Spring Conference 2018. The online \”room\” that will host each session is limited to 1,000 live participants. However, all registered participants will have unlimited access to the recordings of all sessions for six months after the event.
FDA 510 k Clearance & Premarket Approval for Medical Device
Operon Strategist is FDA 510 k process consultant helps the clients to register SBU (Small Business Unit), if applicable. Take out the testing requirement of the product, creation of the dossier, resolving the queries and after completion of all the activities.
The goal of this conference is to provide direct, relevant, and helpful information on the key aspects of drug and device regulations. Our primary audience is that of small manufacturers of drug and/or device medical products who want to learn about how FDA approaches the regulation of drugs and devices.
Because the regulatory principles of drugs and devices are both similar and different, the REdI Conference features cross-cutting plenary addressing issues which impact both drugs and devices, as well as individual break-out sessions which focus on the unique issues and regulatory requirements of drugs and devices.
