Understanding the FDA "Refuse to Accept" Guidance to Avoid Administrative Rejection of your 510(k)

Duration: 60 Minutes
This presentation will help attendees navigate the RTA guidance in order to avoid rejection of 510(k) applications for administrative incompleteness.
FDA Refuse to Accept Guidance
Instructor: Cheryl Wagoner
Product ID: 500996

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.

Areas Covered
  • 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)
  • What has changed in this version of the guidance

Why Should you Attend
The guidance was issued on December 31, 2012 entitled "Refuse to Accept Policy for 510(k)'s". It was updated on August 4, 2015 and will be final on October 1, 2015. The premise is that by rejecting applications that are not administratively complete, the Agency will be able to more efficiently conduct its substantive reviews for safety and efficacy. The Refuse to Accept Policy for 510(k)'s guidance (RTA) includes acceptance criteria in the form of checklists to assist industry and FDA to ensure administratively complete traditional, abbreviated, and special 510(k) applications. This guidance mirrors the "Acceptance and Filing Review for Premarket Approval Application (PMAs)" to a large extent. The 2015 update provides clarification in the checklists, removes potentially confusing language, and administrative updates to references, guidance and web links.

Objectives of the Presentation
  • Understand what has changed since the last guidance
  • Understand how to structure your 510(k) to minimize the likelihood of administrative rejection
  • Understand how RTA impacts the review timeline
  • Understand how FDA will notify you regarding acceptance/rejection of an application
  • Understand the differences in the RTA checklist across the different types of 510(k)
Who can Benefit
  • Regulatory staff/associates with responsibility to compile 510(k) filings
  • Regulatory management
$375
Recorded Session for one participant
Get life time access with download option!
Book This Course
  $500.00 Training CD
Free shipment within 7 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
  $600.00 Flash Drive
Free shipment within 7 Working Days, from the date of webinar completion. Get life time access for unlimited participants.
For multiple location please contact our customer care team +1-510-857-5896.
Do you want to Host
this webinar at your Organization!
Call us at +1-510-857-5896
Email us at webinar@onlinecompliancepanel.com
Minimum 10 attendees
How it works
Live Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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 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). She completed the RAPS Executive Development Program at the Kellogg School of Management.
View More