Clear as Mud: Obtaining & Marketing your 510(K) with Today`s FDA 2012

Topics

• Regulations, statute and guidance documents in the 510(k) program
• Update on the activities and political issues of the FDA and Congress on the 510(k) program
• Marketing your 510(k)
• Common mistakes seen in drafting and prosecuting 510(k)s through the regulatory process

Clear as Mud: Obtaining & Marketing your 510(K) with Today`s FDA brings together VPs, Directors and Heads of: Quality Assurance, Compliance, Validation & Regulatory Affairs, CEOs, Attorneys, Regulatory affairs, Risk Managers, Quality Assurance, Quality Engineering, Risk Management team members, Clinical, Market Research, Production, MDR Reporters, Professionals involved with premarket notification to the FDA, Engineering & R&D, Sales personnel involved in approving the marketing of medical device and R&D personnel involved in approving the design of medical devices.