www.fdanews.com/articles/122613-cber-proper-submission-format-may-speed-review-of-devices
CBER: Proper Submission Format May Speed Review of Devices
December 4, 2009
Manufacturers
with devices regulated by CBER may accelerate reviews if they submit documents in the correct binding and format detailed in new standard operating procedures
and policies (SOPP) for the center’s
staff. In its first written SOPP detailing regulatory document submission requirements that staff should share with sponsors, CBER includes specific recommendations
for submitting investigational device exemptions and medical device applications.
Devices & Diagnostics Letter
Devices & Diagnostics Letter