Exploring the FDA's Refuse to Accept Policy

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Exploring the FDA's Refuse to Accept Policy
Denied
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• 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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• 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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• 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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• 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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• Who can Benefit
• Regulatory Personnel
• Clinical Trial Physician / Doctor
• Manager to Senior Director / VP
• Institutional Review Board
• IT

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• 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
  QA 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.

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