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

NameDescriptionTypeConstraints
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
P160052QIAGEN IncPartoSure testToxicology2018-04-11Partosure PASProtocol Pending
P170034Ivantis; Inc.HYDRUS MICROSTENTOphthalmic2018-08-10Continuation of Premarket Cohort PASProtocol Pending
P180010W. L Gore & Associates; IncGore Carotid StentCardiovascular2018-11-01SCAFFOLD Continued f/u studyStudy Pending
P150040 S003Carl Zeiss Meditec; Inc.VisuMax Femtosecond LaserOphthalmic2018-10-04VisuMax SMILE New EnrollmentProtocol Pending
P180007Spiration; Inc.Spiration® Valve SystemAnesthesiology2018-12-03EMPROVE Extension StudyProtocol PendingProspective Cohort Studytrue
P170043Glaukos CorporationiStent inject Trabecular Micro-Bypass System (Model G2-M-IS)Ophthalmic2018-06-21New Enrollment PASProtocol Pending
P930016 S053AMO Manufacturing USA; LLCiDESIGNRefractive Studio; STAR Excimer Laser SystemOphthalmic2018-06-15Post-Approval StudyProtocol Pending
P100006BIOMIMETIC THERAPEUTICS;LLCAUGMENT BONE GRAFTOrthopedic2015-09-012-year New Enrollment StudyTerminatedStudy questions no longer relevant
H170002Kaneka Pharma America LLCLIPOSORBER LA-15 SystemGastroenterology/Urology2018-03-20New Enroll PAS LIPOSORBER LA-15 AdultsProtocol Pending
P180007Spiration; Inc.Spiration® Valve SystemAnesthesiology2018-12-03SVS Post-Market Registry StudyProtocol PendingProspective Cohort Studyfalse
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