Post-Approval Studies

Post-Approval Studies

• In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
• The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
• CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
• In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.

Links

• Guidance Document: "Procedures for Handling Post-Approval Studies Imposed by PMA Order"
• PAS Webpage FAQs
• Tools for Conducting PAS
• Letter to IRB Chairs (formerly referred to as "IRB Letter from Dr. Schultz (dated 2/9/09)"
• Letter to PAS Participants
• Letter to PAS Investigators
• Post-Approval Studies Workshops
• Report on Implementation of Post-Approval Studies for Medical Devices Workshop (June 2009)

Contact Information

Julie Unger
Project Manager, Post-Approval Studies Program
Food and Drug Administration
10903 New Hampshire Ave
WO66-4206v Silver Spring, MD
20993-0002

Phone: (301) 796-6134
Fax: (301) 847-8140
julie.unger@fda.hhs.gov

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General

Application Number

P080013

Protocol Approved

06/29/2010

Study Name

DuraSeal Exact Spine Sealant System

Study Status

Progress Inadequate

Study Progress Reason

Subject enrollment milestones not met

General Study Protocol Parameters

Study Design

Prospective & Retrospective Study

Study involve follow-up of premarket cohort (Y/N)

No

Data Source

New Data Collection

Comparison Group

Concurrent Control

Analysis Type

Analytical

Study Population

Transitional Adolescent A: 18-21 yrs, Adult: >21

Detailed Study Protocol Parameters

Study Design Description

This multi-center, non-randomized study with a prospective treatment arm and a retrospective control arm  

Study Population Description

Subjects who undergo a spinal procedure where DuraSeal Exact Spine Sealant (prospective arm only) or

Standard of Care (retrospective control arm only) is administered for the treatment of either an intentional or incidental opening of the dura

 

Sample Size

treatment arm and control arm

Data Collection

The primary endpoint is the occurrence of post-operative CSF leaks within 90 days after the

spine surgical procedure. Secondary endpoints are the occurrence of the following events (within 90 days following the surgical procedure): 1) Deep Surgical Site Infections (DSSI) as defined per the CDC guidelines; 2) All neurological SAEs

 

Followup Visits and Length of Followup

90 days post-operation

DuraSeal Exact Spine Sealant System Schedule

Report Schedule	Report Date Due	FDA Receipt Date	Reporting Status
6 month interim report	07/06/2010	07/06/2010	On Time
1 year report	09/04/2010	11/12/2010	Overdue/Received
2 year report	09/04/2011	09/21/2011	Overdue/Received
6 month report	03/04/2012	03/02/2012	On Time
3 year report	09/03/2012	10/01/2012	Overdue/Received
4 year report	09/03/2013
5 year report	09/03/2014

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