Introduction to Risk Management
This three hour overview of financial risk management will provide the fundamentals to risk management that all managers need to comprehend.
It will also increase the burdens on industry. For example, if finalized, there will be a new subclass of Class 2 products for which clinical studies will be required. You will learn of possible changes in the de novo
process that could streamline the clearance process. There will be new definitions of "Substantial Equivalence" and "intended Use" will be redefined and "Indications for Use" eliminated The FDA will likely increase the requirements for the Summary of Safety and Effectiveness and require a summary of all scientific information known or that should be reasonably known to the submitter regarding the safety and/or effectiveness of the device under review. 510(k) submitters would have to provide photographs and design schematics along with detailed device descriptions, which would be available to the public on a revamped 510(k) database. In an attempt to keep up with the rapid pace of innovation in the medical device industry, the FDA plans to issue "Notice to Industry" letters to alert industry to changes in regulatory expectations by FDA for a particular group of devices, plus much more!
Why you should attend: Anyone involved in preparation of 510(k)s or has products with 510(k) clearance should be concerned about the wide-ranging changes proposed by the FDA in the way 510(k)s are reviewed and regulated. While it will take some time for the FDA to finalize its regulations, some changes could be implemented in weeks or months. Therefore, it is prudent to get an overview of the type of changes being considered and the potential impact on your company and products. Comments are being accepted by the FDA now for a limited time.
Areas Covered in the Session:
Who Will Benefit:
- How the de novo classification process may be streamlined to permit lower-risk novel devices to reach the market faster
- What changes are being considered be made to better train reviewers.
- How FDA proposes to use outside experts and the web to tap into outside sources of knowledge.
- Why FDA feels that it needs a class Ilb designation for those class II devices for which clinical and/or manufacturing information would be required
- How FDA would use a "Notice to industry" to communicate changes in regulatory expectations for groups of devices.
- How changes in definitions of key terms in the FDA 510(k) review process, such as Intended Use" and "Indications for Use" could impact the process.
- Understand how FDA's proposed Center Science Council would promote more consistent, science-based reviews.
- Why FDA wants to vastly expand the Summary of Safety and Effectiveness requirement to require inclusion of all scientific information reasonaly known to the submitter regarding the safety and/or effectiveness of the device that is the subject of the 510(k).
- How an enhanced FDA database could save industry time and effort in locating information for the 510(k) submission.
- Why FDA may prohibit use of a particular predicate device
- When FDA would consider rescinding a 510(k)
- Regulatory Affairs Departments in medical device companies
- Regulatory Consultants