The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: March 20, 2014 at 8:30am to March 21, 2014 at 4:30pm
Location: Orlando Airport Marriott
Street: 7499 Augusta National Drive
Website or Map: http://www.complianceonline.c…
Event Type: life, science
Organized By: ComplianceOnline
Latest Activity: Feb 4, 2014
Importing products regulated by the FDA has become more complicated. The FDA is using increasingly strict criteria. In order to ensure that your imported product does not get detained or refused entry, you should be knowledgeable about FDA requirements for foods, medicines, medical devices, cosmetics and radiation emitting devices. In addition, there are import requirements that are enforced by U.S. Customs and Border Protection (CBP) and intersect with the FDA’s legal requirements.
When products are detained, the situation becomes a very costly problem, and a firm needs to know what its options are and how it will resolve the detention quickly. Detentions can hold up a product for months only to have it re-exported or destroyed at your expense. The FDA’s use of automatic detention procedures makes it increasingly difficult to conduct an import business. A foreign manufacturer may receive a “Warning Letter” from the FDA or an inspectional “483.” You need to know how a FDA regulatory action affects your import business and what to do before that action dries up your import pipeline. Understanding all of these and other issues related to product detentions and how to deal with it, how US customs laws and FDA laws intersect etc. is critical to a firm’s successful import business and help reducing the commercial disadvantages it creates.
With what you learn in this seminar, you can work more productively and mitigate the risk of FDA detention. A high-ranking ex-FDA insider will give you straight talk on how FDA operates and the agency’s mindset. You will learn practical information, such as how to interact with FDA, the options you have to resolve problems and how you can prevent problems in the first place.
The FDA’s regulatory controls for imported and exported devices have become increasingly pervasive and stringent. Foreign manufacturers, foreign exporters and domestic initial importers face greater scrutiny and are subject to expensive consequences if they do not plan carefully. Attendees need to understand the FDA’s and the US Customs Border Patrol’s regulatory criteria, inter-agency agreements and intra-agency procedures. The conference provides attendees with the opportunity to understand their work’s inter-relationship with other attendees’ roles.