Attachment E-Sample Task Order Statement of Work

Contractor-Hosted Fully Integrated Records Facility (FIRF) IDIQ Recompete Request for Proposal (RFP) No. 75F40126R00009
Attachment E: Sample Task Order Statement of Work
Title of Task Order: FDA/CDRH Premarket/Postmarket Tracking Services Attachment E
Sample Task Order Statement of Work
Title of Task Order: FDA/CDRH Premarket/Postmarket Tracking Services 1.

Background

The mission of the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH accomplishes its mission through the evaluation of new devices for marketing, developing and monitoring product quality and performance standards, acting against firms that violate the law, educating professionals and consumers on the safe use of devices, and performing research on device problems. CDRH develops and implements national programs to protect the public health in the fields of medical devices and radiological health. These programs are intended to ensure the safety, effectiveness, and proper labeling of medical devices.
CDRH receives, reviews, and renders determinations or otherwise acts upon thousands of premarket and postmarket submissions each year from device manufacturers and others seeking clearance to market or clinically test new or modified devices in the United States. CDRH maintains internal and public databases and records that provide up-to-date information to the Agency, other Federal agencies, and (where appropriate) industry and the public regarding the Center’s recent and historic actions and determinations on premarket submissions. CDRH also reports to industry, Congress, and the public on review timelines and other performance metrics associated with those actions and determinations.
Maintenance of these databases and records depends upon accurate and timely processing and tracking of premarket submissions, and upon appropriate retention and disposal of records. In support of its mission, CDRH receives, tracks, and processes all premarket and postmarket submissions for records retention/disposal purposes. The execution of all tracking and archiving functions includes mail receipt, mail processing, mail distribution to and from divisions, operational functions, jacketing and labeling, electronic submission, user fee and eCopy processing, district office mail, and storage. This includes fulfilling all incoming and outgoing processing and quality control (QC) requirements on a same day as received basis. A late delivery is defined as physical