This 510(k) webinar will help you understand the proposed changes to 510(k) process in 2011 and the regulatory process of implementing it.
Areas Covered in the Seminar:

• Redefinition of terms such as Intended Use/Indications for Use, limiting use of predicates, consideration of off-label uses, greater authority to rescind 510(k)s and other changes.
• Understand recommendation for a new subclass of Class 2 products for which clinical studies will be required.
• Learn of possible changes in the de novo process that could streamline the clearance process.
• Obtain latest recommendations and comments from various device trade groups.
• How will the expected changes affect device makers?
• What additional costs might device makers face in light of new regulatory requirements?
• What will the proposed changes mean for the number of devices cleared?
• How will the proposed changes affect so-called "split-predicates"?
• What is the regulatory process for implementing the recommendations?
• What can device companies do to prepare for upcoming changes?
• Industry needs to prepare for these “likely” statutory changes in 2011

Who Will Benefit:
This webinar will provide valuable assistance and guidance to device and IVD companies involved in any aspect of the 510(k) process. Employees who will benefit include:

• All levels of management and departmental representatives any anyone who desire a better understanding or a "refresh" overview of the proposed changes
• Regulatory Affairs/RA Specialists
• Clinical Affairs
• Quality and Compliance
• Marketing & Sales
• Distributors/Authorized Representatives
• Engineering/Technical Services/Operations
• Consultants

For Registration:
http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=701854?channel=biofind
Note: Use this promocode(117660) for 10% discount.