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
Note: Use this promocode(117660) for 10% discount.