FDA Post Approval Studies Database

$79 / year

The Post-Approval Studies (PAS) Database identifies the reporting status of PAS studies 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. Post-approval studies (PAS) are conditions of device approval. A sponsor’s failure to comply with any post-approval requirement may be grounds for withdrawing approval.

Complexity

CDRH’s Post-Approval Studies Program ensures that methodologies are well-designed and conducted effectively, efficiently and in the least burdensome manner. In 2005, the Division of Epidemiology (DEPI) in CDRH’s Office of Surveillance and Biometrics (OSB) assumed responsibility for overseeing the program. Along with OSB, other CDRH offices including the Office of Device Evaluation (ODE), and the Office of In-Vitro Diagnostics and Radiological Health (OIR), share PAS Program responsibilities for design, tracking, oversight, and review of these mandated studies.

CDRH has established the Post-Approval Studies Database to share general information regarding each PAS ordered since January 1, 2005, provides the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant’s current reporting status for each submission due. The database refreshes every Sunday with any new or revised information on study protocol parameters (e.g., patient population), overall study status, or information related to the review of data from interim or final reports.

Date Created

2005

Last Modified

2018-04-11

Version

2018-04-11

Update Frequency

Irregular

Temporal Coverage

1991-09 to 2018-04

Spatial Coverage

United States

Source

John Snow Labs => Food and Drug Administration (FDA)

Source License URL

John Snow Labs Standard License

Source License Requirements

N/A

Source Citation

N/A

Keywords

CDRH and Applicants, CDRH’s Post-Approval Studies, Post-Approval Studies, PAS, Post-Approval Device

Other Titles

Post-Approval Studies, Medical device Post-Approval Studies

Name Description Type Constraints
Application_NumberPAS Application Numberstringrequired : 1 maxLength : 12
Applicant_NameThe Applicant Namestringrequired : 1
Device_NameMedical Device Namestringrequired : 1
Medical_SpecialtyMedical Specialty of the Medical Devicestringrequired : 1
Date_PMA_ApprovedPremarket-Approval (PMA) Approved Datedaterequired : 1
Study_NameMedical Device Study Namestringrequired : 1
Protocol_Accepted_DateThe Protocol Accepted Datedate-
Current_Protocol_Accepted_DateThe Current Protocol Accepted Datedate-
Study_StatusThe status of the study determined by the FDA After the review of a supplement with a protocol or of an interim or final report.string-
Study_Progress_ReasonMedical device study progress reasonstring-
Study_DesignMedical device study designstring-
Is_Study_Involve_Follow_Up_Of_Premarket_CohortStudy involve follow-up of premarket cohortboolean-
Data_SourceThe Data sourcestringenum : Array
Comparison_GroupMedical device comparison groupstring-
Analysis_TypeMedical device analysis typestringenum : Array maxLength : 11
Study_PopulationMedical device study populationstring-
Study_Design_DescriptionMedical device study design descriptionstring-
Study_Population_DescriptionMedical device study population descriptionstring-
Sample_SizeStudy sample sizestring-
Data_CollectionData collectionstring-
Followup_Visits_and_Length_of_FollowupFollowup Visits and Length of Followupstring-
Actual_Number_of_Patients_EnrolledActual Number of Patients Enrolledstring-
Actual_Number_of_Sites_EnrolledActual Number of Sites Enrolledstring-
Patient_Followup_RatePatient Followup Ratestring-
Final_Safety_FindingsFinal medical device safety findingsstring-
Final_Effectiveness_FindingsFinal effectiveness findingsstring-
Study_Strengths_and_WeaknessesMedical device study strengths and weaknessesstring-
Recommendations_for_Labeling_ChangesRecommendations for medical device labeling changesstring-
Application_NumberApplicant_NameDevice_NameMedical_SpecialtyDate_PMA_ApprovedStudy_NameProtocol_Accepted_DateCurrent_Protocol_Accepted_DateStudy_StatusStudy_Progress_ReasonStudy_DesignIs_Study_Involve_Follow_Up_Of_Premarket_CohortData_SourceComparison_GroupAnalysis_TypeStudy_PopulationStudy_Design_DescriptionStudy_Population_DescriptionSample_SizeData_CollectionFollowup_Visits_and_Length_of_FollowupActual_Number_of_Patients_EnrolledActual_Number_of_Sites_EnrolledPatient_Followup_RateFinal_Safety_FindingsFinal_Effectiveness_FindingsStudy_Strengths_and_WeaknessesRecommendations_for_Labeling_Changes
P160052 QIAGEN IncPartoSure testToxicology2018-04-11OIR Lead-Partosure PASProtocol Pending
P160039 RESPICARDIAremede® SystemAnesthesiology2017-10-06ODE Lead-Post-Approval StudyProtocol Pending
P100047 S090MedtronicHeartWare™ HVAD™ SystemCardiovascular2017-09-27OSB Lead-ENDURANCE PASProtocol Pending
P150009 ANGEL MEDICAL SYSTEMS INC.ANGELMED GUARDIAN SYSTEMCardiovascular2018-04-09OSB Lead-AngelMed Guardian PASProtocol Pending
P160013 TransMedics; IncOrgan Care System (OCS™) Lung SystemGastroenterology/Urology2018-03-22OSB Lead-TOP PAS RegistryProtocol Pending
P810002 S101St. Jude Medical; Inc.SJM Masters Series Mechanical Heart Valve; 15mm HPCardiovascular2018-03-06OSB Lead-HALO PASProtocol Pending
P160013 TransMedics; IncOrgan Care System (OCS™) Lung SystemGastroenterology/Urology2018-03-22ODE Lead-INSPIRE Continuation PASStudy Pending
P050006 S060W.L. GORE & ASSOCIATES;INCGORE CARDIOFORM Septal OccluderCardiovascular2018-03-30ODE Lead-Continued f/u of IDE CohortStudy Pending
P160055 RxSight; Inc.LIGHT ADJUSTABLE LENS (LAL) AND LIGHT DELIVERY DEVICE (LDD)Ophthalmic2017-11-22OSB Lead-LAL/LDD Postmarket RCTProtocol Pending
P050006 S060W.L. GORE & ASSOCIATES;INCGORE CARDIOFORM Septal OccluderCardiovascular2018-03-30OSB Lead-GORE CARDIOFORM New Enrollment PASProtocol Pending