The FDA recently published a final guidance, “eCopy Program for Medical Device Submissions” to describe the new electronic (eCopy) Program for medical device submissions. The guidance, effective Jan. 1, requires eCopy submission for most types of device applications, including 510(k)s. eCopies are required to contain all information and data necessary for FDA review in electronic form. Because electronic versions are available immediately, the FDA hopes that eCopy submission will expedite the medical device review process. To read the final guidance, click here.
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