Research and Markets: FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy: 2-day In-Person Seminar - 13-14th November, Salt Lake City, UT
DUBLIN--(BUSINESS WIRE)--Research and Markets (http://www.researchandmarkets.com/research/sv544m/fdas_refuse_to) has announced the addition of the "FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy: 2-day In-Person Seminar" conference to their offering.
“FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy: 2-day In-Person Seminar”
Each year the FDA receives approximately four thousand 510(k) Notifications per year. Starting in January, 2014, the FDA began enforcing the FDA's Refuse to Accept Criteria for a 510(k) Notification submission. Obtaining market clearance in a timely manner allows a company to bring new or improved products to market sooner. One of the key steps in submitting a 510(k) Notification is selecting the predicate device and being able to show substantial equivalence between your device and the predicate device.
This 2 day course will show how to submit a traditional, abbreviated and special 510(k) for a Class II Medical Device. It will discuss what to look for in a predicate device and how to show substantial equivalence. This includes visual, dimensional and functional comparisons.
Upon receipt of a 510(k), the FDA reviews the 510(k) within 15 days as part of the Refuse to Accept Policy to verify that all of the required elements are included in the 510(k) submission. This course will review the FDA's Acceptance Checklist for 510(k) s that the FDA uses for the Refuse to Accept Review and also provide helpful hints for passing the FDA's initial review.
- Difference between a traditional, abbreviated and special 510(k) and when to submit each type of 510(k)
- When to file for a new device, a change in the intended use or a change in the technology of a cleared device
- What is contained in a traditional, abbreviated and special 510(k) submission package
- The submission package, user fees and making an eCopy
- What is substantial equivalence and what's required to show substantial equivalence
- What's required on the labeling and IFU
- Which performance tests should be conducted and how to present the data to the FDA
- The requirements for a risk management plan and report
- Understand the FDA's Refuse to Accept Policy
- What is required in a submission for software controlled devices
- How and when to use third party reviews
- When clinical data may be required
Who Will Benefit:
- Company CEOs and Presidents
- Regulatory Affairs Managers
- Quality Assurance Managers
- Regulatory and Quality Assurance Professionals
- Design Engineers
- Quality Engineers
- Legal Professionals
For more information visit http://www.researchandmarkets.com/research/sv544m/fdas_refuse_to