In the fall of 2013, the FDA released updated draft guidance on a new digital medical device submission system known as the eCopy Program.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
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
This webinar has been pre-approved by the Regulatory Affairs Professionals Society (RAPS) as eligible for up to 1.5 credits towards a participant’s RAC recertification upon full completion.
Clinical and Regulatory Affairs Consultant
Shira comes from SI-BONE, Inc.’s Clinical and Regulatory departments where she assists with their eCopy submissions and overall work with clinical trials. Prior to that she was at Varian Medical, where she worked as a Regulatory Submissions Specialist and assisted in 510k submissions clinical writing. Prior to Varian Medical, Shira held clinical and regulatory positions at start-ups and companies such as Covidien, ev3, and Chestnut Medical where she assisted on 510ks, PMAs, IDEs, clinical document support and supporting CRAs for the company’s clinical trials.