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Technical Standards and Guidance for FDA’s e-Copy Submission Program
Technical Standards and Guidance for FDA’s e-Copy Submission Program


 
Our Price: $395.00

Product Code: WB-7073
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About the Product
Includes 50 minute Windows Media Video File and PowerPoint presentations for immediate download.


In the fall of 2013, the FDA released updated draft guidance on a new digital medical device submission system known as the eCopy Program. Under the FDA Safety and Innovation Act (FDASIA), an eCopy is defined as “an exact duplicate of the paper submission,” and is required for nearly all medical device submissions, including 510(k), PMA, IDE and pre-submissions. The program is intended to ease the amount of time FDA needs to enter this information into its databases and should also make the review of submissions more consistent and precise. Many within the industry, however, have expressed concern that the program is actually hindering the communication process with FDA and slows the clearance and approval process.
  • Understanding technical standards for eCopy submissions
  • Step-by-step explanation of correct submissions
  • Outlining key timelines and deliverables
  • e-Copy exemptions and hold letters
  • Discussing unexpected e-Copy hurdles and future developments
  • Insights for overcoming e-Copy rejections

Speaker:

Shira Stone
Clinical and Regulatory Affairs Consultant
SI-BONE, Inc


Participants that will find this webinar most beneficial will be those involved in medical device companies. Job titles of attendees that will be most applicable for this session will be:

  • Regulatory Affairs


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