Bullet Proof 510(k) - Latest FDA Proposed Changes to the Process 2011

Objectives:
-Know the differences between the Traditional, Special and Abbreviated submissions
-Understand Substantial Equivalence and how it is applied
-Who is required to submit the application to FDA
-Where to submit the 510(k) and what to expect with the review and approval process
-When it is and is not required if you are a device company
-Exemptions to the submission process and special considerations
-How to locate a "predicate" device and go through the content and format of the 510(k)
-Understand the De Novo process and the expectations for possibly marketing a low risk device
-Understand the potential impact of FDA's proposed changes to the 510(k) process and why manufacturers need to pay attention

Detailed Agenda:
-Introduction and Regulatory Background
-There is no 510(k) form; however, 21 CFR 807 Subpart E describes requirements for a 510(k) submission.
-Current trends with the 510(k) process.
-The Process
-Who is Required to Submit a 510(k)
-When a 510(k) is Not Required
-When a 510(k) is Required
-Locating and justifying the Predicate
-Substantial Equivalence and demonstration of SE to another legally U.S. marketed device
-How to Prepare Submissions
-510(k) Submission Methods
-List of forms associated with Premarket Notification 510(k) submissions
-Deciding When to Submit a 510(k) for a Change to an Existing Device
-What happens if FDA requires additional information and data and your responsibilities
-Interactive Q&A, Wrap-Up and Adjourn
-Q&A with all attendees
-Group discussion and review of recent 510(k) clearances and proposals and recommendations between FDA and industry

6:31 PM 10/25/2011
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

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