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U.S. Department of Health and Human Services

Post-Approval Studies (PAS)

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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OSB Lead-Case Control Studies

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Application Number P040046 / PAS004
Study Name OSB Lead-Case Control Studies
General Study Protocol Parameters
Study Design Case Control Study
Data Source New Data Collection
Comparison Group Concurrent Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Design Description Case-control study
Study Population Description Women in the UK with the studied rare diseases (i.e., rare CTDs, rare neurological diseases, brain cancer, cervical/vulvar cancer and lymphoma) as cases and women in the UK without any of the 5 studied rare diseases as controls.
Sample Size For each of the 5 case-control studies, 1,500 cases of women diagnosed with each specific studied rare disease will be identified from the GPRD. A total of 4000 women identified from the GPRD without any of the 5 rare disease outcomes will be enrolled as a control group to the 5 case groups.
Data Collection Patient data will be collected from three sources: the GPRD database, directly from the patient via a structured questionnaire, and if the patient had silicone breast implants, directly from the surgeon who performed the implantation procedure. The study data will be entered into an electronic data capture system (EDC) using an electronic case report form (eCRF). Available data will be abstracted from the GPRD database and entered into the eCRF. The de-identified completed patient questionnaires will also be entered into the EDC. For patients who had breast implants, the surgeon who performed the implantation procedure will be contacted directly to obtain the data on the manufacturer and style of silicone breast implant.

Information obtained from both the cases and controls will include the following:

¿ Data collected from the GPRD database will include date of birth, date at diagnosis (all cases), date of identification from database (controls), socioeconomic status (census area-level based on post code), history of breast cancer, history of oral contraceptive use, tobacco use history, body mass index (BMI), number of live births, age at first pregnancy, age at first live birth

¿ Data collected from the patient will include ethnicity, for cases family history of the studied rare disease (cases), for controls family history of any of the five studied rare diseases, breast implant history (i.e., indication, type, shape, date of implantation, contact information of the surgeon), smoking history, alcohol use history, for controls sexual history

¿ Data collected from the surgeon (if patient had implants) will include date of implant, manufacturer of Implant, style of Implant

Cases will be identified among the diagnoses starting 2004 to allow about 10 years of exposure to the silicone breast implants from the GPRD database.

Follow-up Visits and Length of Follow-up There is no prospective follow-up for case-control studies

OSB Lead-Case Control Studies Schedule

Report Schedule
Date Due
FDA Receipt
Applicant's Reporting Status
six month report 08/21/2013 08/20/2013 On Time
one year report 02/20/2014 02/11/2014 On Time
18 month report 08/27/2014 08/26/2014 On Time
two year report 02/20/2015 02/20/2015 On Time

Contact Us

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

Phone: (301) 796-6134
Fax: (301) 847-8140

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