Medical Devices

Post-Approval Studies (PAS) - Frequently Asked Questions (FAQ)

  1. How do I search the PAS database?
  2. How does the FDA categorize the status of a study?
  3. How does the FDA categorize the sponsor's reporting status?
  4. Can a device have more than one PAS?
  5. How is the PAS program evolving?
  6. What is a comprehensive linked registry based surveillance?
  7. In the PAS database, what is the difference between ODE, and OIR/OSB Lead?
  8. How can I obtain a copy of the PMA approval letter ordering the post-approval study?
  9. How can I obtain a copy of a PAS protocol or final report?

1. How do I search the PAS database?

Select one of the alphabetical buttons at the top of the page to go directly to the studies conducted by applicant names that begin with that letter or sort the data in ascending or descending order by clicking one of the arrows in the column headers:

  • Application Number
  • Applicant Name
  • Device Name
  • Medical Specialty
  • Date PMA Approved

You can also type information in the search box and click on the search button.

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2. How does the FDA categorize the status of a study?

Protocol Overdue - FDA has not approved the study protocol, and it has been 6 months or more since issuance of the order.

Protocol Pending - FDA has not approved the study protocol, and it has been less than 6 months since issuance of the order.

Study Pending - This category is used from the time the protocol has been approved to the review of the first report.

Progress Adequate - The study has begun, and the study progress is consistent with the protocol (e.g., meeting enrollment schedule, follow-up rates, endpoints evaluated).

Progress Inadequate - The study has begun, but the study progress is inconsistent with the protocol (e.g., not meeting enrollment schedule, missing time point evaluations, poor follow-up rates, not all endpoints evaluated).

Completed - The sponsor has fulfilled the condition of approval, and FDA has closed the study.  This is a final study status.

Terminated - The sponsor has not fulfilled or cannot fulfill the condition of approval (device is not currently being sold because the device technology is obsolete, study questions are no longer relevant, sponsor withdraws PMA, study cannot answer post-approval study question), all appropriate efforts to fulfill the condition of approval have been exhausted, FDA has terminated the study.  This is a final study status.

Revised/Replaced - The sponsor has not fulfilled or cannot fulfill the condition of approval due to a failed study.  All appropriate efforts to fulfill the condition of approval have been exhausted, and FDA has agreed to revise and or replace the original study design with a new design to fulfill the condition of approval requirement.  The new design supersedes the failed study design.

Other - This is used when the study status does not fit another category (e.g., sponsor not marketing the device and has no plans to market the device; change in ownership underway; sponsor redesigning device and needs PMA approval prior to use in a PAS; pending separate study being used to address condition of approval).  This is an interim study status.

See PAS guidance document entitled, "Procedures for Handling Post-Approval Studies Imposed by PMA Order."

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3. How does the FDA categorize the sponsor's reporting status?

Report on Time - FDA has received the scheduled Interim or Final Post-Approval Study Status Report by the due date set in the agreed-upon schedule.

Report Overdue - FDA has not received the Interim or Final Post-Approval Study Status Report by the due date set in the agreed-upon schedule.

Report Overdue/Received - FDA has received the Interim or Final Post-Approval Study Status Report, although receipt was after the due date set in the agreed-upon schedule.

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4. Can a device have more than one PAS?

Yes, there can be more than one PAS imposed by a PMA, PDP, or HDE application.

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5. How is the PAS program evolving?

FDA launched the Medical Device Epidemiology Network (MDEpiNet) Initiative in 2010, to develop national/international infrastructure and innovative methodological approaches for conducting robust studies and surveillance, to improve the understanding of medical device safety and effectiveness throughout the device life cycle, through a Public-Private Partnership (PPP) with academia and other stakeholders (www.mdepinet.org). Aligned with these national, international, and MDEpiNet PPP efforts, FDA has been rethinking approaches for mandated studies imposed at the time of device approval.

Consistent with CDRH'S vision for a National Evaluation System, when appropriate, FDA has begun replacing traditional PAS requirements with surveillance based requirements where postmarket infrastructure is in place to support it. Under this model, the manufacturer agrees to support a national/international registry and ensures their device data is captured (e.g. registries, claims).  These requirements are indicated in the PAS database as: "Comprehensive/Linked-Registry Based Surveillance".

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6. What is a comprehensive/linked registry based surveillance?

Registry-based comprehensive surveillance leverages the national and international registry infrastructure that is linked with other data sources (e.g., claims data) for longitudinal assessment of device performance. This type of surveillance is relies on data collection within existing health care delivery systems.  It generally involves shared responsibilities amongst multiple stakeholders, including professional societies running the registries, FDA epidemiologists performing the surveillance analysis, payers assisting with linking to administrative data, and industry supporting the registries).

Under Comprehensive/Linked-Registry Based Surveillance, manufacturers would actively participate as a stakeholder and support a registry to ensure that FDA surveillance can occur for the approved device over a specified period of time.  Manufacturers may not need to submit any progress reports for the surveillance activity if FDA has access to the data and can conduct the analyses for the purpose of surveillance, as well as engage in quarterly discussions with the manufacturer and registry to discuss the findings.

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7. In the PAS database, what is the difference between ODE, OIR, and OSB Lead?

OSB Lead - The Office of Surveillance and Biometrics (OSB) will continue to have the lead for PAS ordered prior to January 1, 2015 and for all PAS for clinical studies ordered after January 1, 2015 initiated after device approval.  This includes any studies involving new enrollments such as: cohort studies (prospective and retrospective), cross-sectional studies, active or enhanced surveillance systems, randomized clinical trials, and/or premarket cohorts supplemented with new enrollments (postmarket).

ODE/OIR Lead - The Office of Device Evaluation or the Office of In-Vitro Diagnostics and Radiological Health (ODE/OIR) will have the lead for all non-clinical PAS (animal testing, bench testing, failure mode tests, long-term stability testing, etc.) as well as PAS ordered after January 1, 2015 for clinical studies that were initiated prior to device approval (i.e., extended f/u of premarket cohorts)

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8. How can I obtain a copy of the PMA approval letter that ordered the post-approval study?

The approval letters, as well as the Summary of Safety and Effectiveness Data (SSED), are posted on CDRH's PMA Approvals webpage.

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9. How can I obtain a copy of a PAS protocol or final report?

Protocols and final study reports can be requested either directly from the applicant or from FDA under the Freedom of Information Act (5 U.S.C. 552) (FOIA). The FDA will comply with the requirements of 21 CFR Part 20 on the disclosure of information.

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Page Last Updated: 08/22/2016
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