In an effort to promote innovation while protecting the population at large, FDA has been on a path to revise the existing regulatory pathway surrounding the 510(k) process for medical devices for several years. This continues to be an area of many questions and considerations. In fact, we’ve devoted a whitepaper to these issues to help researchers understand the 510(k). Recently FDA released a Draft Guidance on the eCopy Program for Medical Device Submissions. While this system is currently voluntary, the draft guidance gives industry an idea of what might be in store for device submissions.