켐론FDA코리아

October 17, 2012

Dear Registered Establishment,

We are happy to announce another milestone in MDUFA III implementation with the publication of the draft guidance on the eCopy program and two final guidance documents on FDA and Industry actions on PMAs and 510(k) submissions.

Today, the FDA issued Draft Guidance for Industry and Food and Drug Administration Staff - eCopy Program for Medical Device Submissions. This draft guidance explains the new eCopy program for medical device submissions and describes how the FDA will implement it once this guidance is finalized.

An eCopy is an exact duplicate of the paper medical device submission and serves as one of the required number of copies for each submission. Upon receipt of a complete eCopy, the FDA will load it into the appropriate center official document repository and will consider that copy to be the official record.

Aside from describing the eCopy program, this draft guidance includes the new technical standards for eCopies that are already in place, such as the eCopy statement in the cover letter, volume versus non-volume structure, folder naming convention, Adobe Acrobat Portable Document Format (PDF) file format, non-PDF file formats, PDF file naming convention, and PDF file size requirements) and a table listing common mistakes and suggested solutions. Because FDA’s eCopy loading system cannot accept eCopies that do not meet the new technical standards, it is critical that submitters carefully follow this section of the guidance.

eCopy submissions will become required after this guidance becomes final; the implementation date for the eCopy program is projected to be Jan. 1, 2013. Until then, we encourage voluntary participation and will continue to accept voluntary eCopies that meet the new technical requirements until the new eCopy program is implemented. Regulatory questions regarding the eCopy program should be directed to CDRH-eCopyinfo@fda.hhs.gov.

You may submit comments and suggestions regarding this draft document within 30 days. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov.

In addition, today the FDA issued two final guidance documents: Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals and Guidance for Industry and Food and Drug Administration Staff - FDA and Industry Actions on Premarket Notification (510(k)) Submissions: Effect on FDA Review Clock and Goals. The guidance documents describe FDA and Industry actions on PMA and 510(k) submissions and the performance goals and process improvements outlined in the letter from the Secretary of Health and Human Services to Congress (the MDUFA Commitment Letter) for PMA and 510(k) submissions received from FY 2013 through FY 2017.

For more information, please see http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/MDUFAIII/default.htm.

Thank you,

Center for Devices and Radiological Health

Food and Drug Administration