FDA Seeks Input on 510(k) eCopy Submission Requirements

Devicemakers can begin taking steps to comply with new electronic copy requirements for most types of FDA submissions, thanks to an FDA draft guidance.

The provision in this summer’s FDA Safety & Innovation Act doesn’t eliminate the need for a paper copy of submissions, but requires devicemakers to include an eCopy along with the paper version.

The draft, released Oct. 17, defines eCopies as exact electronic duplicates of paper submissions. The two may differ only where the electronic version includes content — such as extended raw data or videos — that is impractical, inappropriate or not feasible to submit on paper. “The critical attribute of an eCopy is that it must include in electronic form all data required for that submission type,” the draft states.

eCopies are required for 510(k)s, de novo applications, humanitarian device exemptions and traditional, modular and transitional PMAs.

Electronic submissions are about to go global, and the FDA is leading the way. If you understand the FDA’s requirements, you can satisfy any regulator worldwide.

If you don’t have your electronic submission process perfected, there’s no time to lose. Many drug, biologic and device companies can already measure the difference in dollars — through increased first-time acceptance rates, shorter FDA review times, and yes, speed to market. And with FDAnews’ Preparing for the New Electronic Submission Mandates, you can add your company’s name to the prepared list.