文件名称：510(k)-for-a-Change-to-an-Existing-Device.pdf
文件大小：1.04MB
文件格式：PDF
更新时间：2023-04-25 00:00:45
FDA 510K HARDWARE
Deciding When to Submit a 510(k) for a Change to an Existing Device Guidance for Industry and Food and Drug Administration Staff Document issued on October 25, 2017. The draft of this document was issued on August 8, 2016. This document supersedes Deciding When to Submit a 510(k) for a Change to an Existing Device, dated January 10, 1997. For questions about this document regarding CDRH-regulated devices, contact the 510(k) Staff at 301-796-5640. For questions about this document regarding CBER-regulated devices, contact the Office of Communication, Outreach, and Development (OCOD) at 1-800-835-4709 or 240-402-8010.