Webinar on what the FDA expects for a 510K submission. FDA has initiated methods to ensure that 5 10Ks meet a minimum threshold of acceptability.

1. Exploring the FDA's Refuse to Accept
Policy
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2. Instructor Profile:
Angela Bazigos, is the CEO of Touchstone Technologies Silicon Valley, Inc.
"Knowledge is Power". She has 35 years of experience in the Lifesciences industry
spanning GLP, GCP, GMP, Medical Devices & 21 CFR 11 and has a patent aimed at
speeding up Software Compliance.
Ms. Bazigos is a Past President of PRCSQA, a member of the SQA CVIC, ASQ, DIA
and RAPS. She works closely with the FDA on behalf of her clients. She consults to
Life Science Investment Groups as well as to Pharma / Biotech / Medical Device
companies on compliance matters, including strategy, submissions, quality
assurance and remediation's following action by the FDA.
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3. Description:
The Office of Device Evaluation (ODE)
receives approximately 6500 Premarket
Notification (5100) submissions every
year. Many of these submissions are
incomplete or grossly inadequate, as they
fail to contain the components necessary
to allow substantive review of the
submission and inappropriately consume
Center resources. As a means to employ
more effectively the Center's resources,
the FDA has implemented procedures to
ensure that 5 10Ks meet a minimum
threshold of acceptability; otherwise the
Center will refuse to accept the
submissions for substantive review.
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4. Why Should you Attend:
The FDA has instigated a Refuse to Accept Policy and will no longer
accept 510K submissions that do not meet a minimum threshold of acceptability.
By doing so, the Center for Devices and Radiological Health, will be able to focus
substantive review on submissions that are complete. It is expected that 510(K) s
that are accepted under this new policy, will be reviewed more quickly.
In this webinar, you will learn what the FDA expects for a 510K submission. By
following the principles outlined in this webinar, you will minimize the risk of your
submission being rejected and you will increase the potential for a speedy review
and approval by the agency.
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5. Objectives of the Presentation:
The objectives of this webinar are to talk in detail about:
• FDA's Guidance on Refuse to Accept
• Pre-Submission Interaction
• 510(K) Refuse to Accept Policies and Procedures – High
Level
– The 510(k) Checklist
– FDA Review Clock
– Notification of Acceptance Review Result
• Refuse to Accept Principles - Details
• Refuse to Accept Checklist - Details
• Acceptance Review Checklist – Details
• Traditional vs Non-Traditional 510(K)s
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6. Who can Benefit:
• Regulatory Personnel
• Clinical Trial Physician / Doctor
• Manager to Senior Director / VP
• Institutional Review Board
• IT
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7. Live Session - How it works
• Username and Password will be sent
to you 24 hours prior to the webinar
• Presentation handouts in pdf formate
will be mailed to you
• Login to the session using the
username and password provided to
you
• Get answer to your queries through
interactive Q&A sessions via chat
• Please let us know your thoughts and
views at the end of webinar, your
valuable feedback will help us
improve
• Get certification of attendance.
Recorded Session - How it
works
• A link will be provided to you upon
purchase of the recorded session
• Please click on the link to access the
session
• Presentation handouts in pdf formate
will be mailed to you
• Get certification of attendance.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com

8. Get Connected :
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com