CBER: Proper Submission Format May Speed Review of Devices

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