FDA's Refuse to Accept Policy - How to Prepare 510 (K) Submission to Avoid the Pitfalls of the Policy

Each year the FDA receives approximately four thousand 510(k) Notifications per year. In the last few years the FDA has made significant changes to the 510(k) Notification process should as the institution of the FDA’s Refuse to Accept Criteria for a 510(k) Notification submission and limiting the number of predicate devices that can be used to show substantial equivalence. Obtaining market clearance in a timely manner allows a company to bring new or improved products to market sooner.

This 2 day course will detail the requirements of a 510(k) submission. The course is interactive and each participant is encouraged to ask questions about specific products. The contents and rational for submitting a traditional, abbreviated and special 510(k) for a Class II Medical Device will be detailed. In addition, comparison tables to show substantial equivalence will be reviewed.

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.

Upon completing this course participants will understand:

• 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

Who Will Benefit:

This course is designed for individuals who are tasked with preparing a 510(k) Notification or part of a team preparing a 510(k) Notification. The following personnel will benefit from the course:

• Company CEOs and Presidents
• Regulatory Affairs Managers
• Quality Assurance Managers
• Regulatory and Quality Assurance Professionals
• Design Engineers

Note:

Use coupon code NB5SQH8N and get 10% off on registration.

For Registration:

http://www.complianceonline.com/fda-510k-refuse-to-accept-policy-avoiding-pitfalls-of-510k-submissions-seminar-training-80185SEM-prdsm?channel=sciencedz