Understanding the FDA ''Refuse to Accept'' guidance to avoid administrative rejection of your 510(k)

Why Should You Attend:

FDA’s efforts to be more efficient are good for industry. However, if you don’t adhere closely to the RTA guidance, a 510(k) application may be rejected for lack of administrative completeness. If an application is rejected, time delays are incurred while the deficiencies are addressed. Once corrected, the application may be resubmitted and a new 15 day clock begins. These delays could be costly in getting new technology or significant enhancements to existing technology cleared and onto the US market.

This presentation will help attendees navigate the RTA guidance in order to avoid rejection of 510(k) applications for administrative incompleteness.

Areas Covered in the Webinar:

• Scope of the Refuse to Accept 510(k) guidance
• Structuring 510(k) to minimize likelihood of rejection
• FDA Review Clock
• Notification of Acceptance
• What is not part of the RTA review
• Checklist Preliminary Questions
• Checklist Acceptance Review
• Differences in the checklists between Traditional, Abbreviated, and Special 510(k)

Who Will Benefit:

This webinar will provide valuable assistance to:

• Medical device regulatory affairs
• Medical device product managers
• Documentation
• Medical device quality assurance
• Clinical professionals

Instructor Profile:

Cheryl Wagoner, has 20 years of experience in quality assurance, and regulatory affairs. She currently is the Principal Consultant/Owner of Wagoner Consulting LLC, where she provides consulting services to medical device and pharmaceutical companies. Previously, she has held various positions in Quality, Regulatory, Clinical and Compliance in the medical device and pharmaceutical industries.

Cheryl is a member of Regulatory Affairs Professionals (RAPS), Association for the Advancement of Medical Instrumentation (AAMI), Medical Device Manufacturers (MDMA) FDA Working Group, and the MDMA Compliance Working Group. She completed the RAPS Executive Development Program at the Kellogg School of Management. She also presented “Develop a Publication Strategy with KOLs during Clinical Development” at CBI’s 8th Annual Forum on Interactions with Thought Leaders and Key Opinion Leaders (KOLs) as well as served as a panelist for “Transparency Strategies and Their Impact on Relationships with Thought Leaders”.

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