Mastering Post-Approval Studies (PAS): A Strategic Guide for Medical Device Manufacturers

Navigating the post-market phase of medical device regulation in the U.S. requires careful planning, especially for devices approved via the Premarket Approval (PMA) pathway. While not all devices require post-market studies, the FDA has the authority to mandate Post-Approval Studies (PAS) for devices approved under PMA or the Humanitarian Device Exemption (HDE). 

At BioBoston Consulting, we help medical device companies design, implement, and manage PAS programs that meet FDA expectations and support continued product safety and effectiveness. 

 

What Is a Post-Approval Study (PAS)? 

A Post-Approval Study is a form of post-market surveillance required by the FDA to gather additional data on a device’s safety and efficacy after it has entered the market. This requirement is most common for high-risk devices cleared via PMA or HDE pathways. 

The FDA may require a PAS when there’s uncertainty around long-term benefits or risks, even if the device’s overall benefit-risk profile was acceptable during the premarket review. In such cases, PAS helps provide a higher level of regulatory assurance over time. 

 

FDA Expectations for PAS Protocols 

When the FDA conditions a PMA approval on conducting a PAS, it expects manufacturers to work closely with the agency to define a robust study protocol. The FDA encourages early engagement during the PMA review process to align on the PAS design, scope, and reporting milestones. 

Key components of a PAS protocol include: 

• Regulatory background and device indication 

• Purpose and clearly defined study objectives 

• Study design and population (with inclusion/exclusion criteria) 

• Enrollment strategy and milestone timelines 

• Sample size and statistical justification 

• Primary and secondary endpoints 

• Follow-up duration and visit schedule 

• Adverse event reporting framework 

• Data collection and analysis methodology 

• IRB approvals, consent forms, and compliance tools 

• Detailed study timeline 

Once approved, any significant changes to the PAS protocol must be resubmitted to the FDA for additional review. 

 

What is the Timeline for PAS Protocol Approval? 

There are two primary scenarios for PAS protocol review: 

• At Time of PMA Review:
  If a PAS is anticipated, the FDA prefers to review the full protocol alongside the PMA. This ensures alignment on PAS goals and eliminates delays after approval. 

• Post-PMA Approval (with Outline):
  If the full PAS protocol is not ready, the FDA may approve the PMA with an outline of the study design. In this case, the full PAS protocol must be submitted within 30 calendar days of the PMA approval. The FDA will review and respond within another 30 days. 

At BioBoston Consulting, we assist clients in drafting FDA-compliant PAS protocols, facilitating early alignment with regulators, and reducing risks of delays or rejections. 

 

PAS Enrollment Timelines: What You Need to Know 

The FDA outlines strict enrollment milestones to ensure timely study execution: 

• First subject enrolled: Within 6 months of protocol approval 

• 20% enrollment: Within 12 months 

• 50% enrollment: Within 18 months 

• 100% enrollment: Within 24 months 

Sponsors are expected to monitor and report enrollment status and maintain frequent communication with the FDA to stay on track. 

 

PAS Reports: Enrollment, Progress & Final Reporting 

To ensure transparency and ongoing oversight, the FDA requires manufacturers to submit three types of PAS reports: 

• Enrollment Status Report:
  Tracks progress toward enrollment milestones. 

• PAS Progress Report:
  Includes interim data, safety updates, and identifies any delays or challenges in study execution. 

• Final PAS Report:
  Submitted no later than three months after study completion. It summarizes final outcomes, device performance, and long-term safety and effectiveness data. 

BioBoston Consulting can support full report preparation and submission, ensuring your study stays compliant with evolving FDA post-market surveillance expectations. 

 

Key Considerations for a Successful PAS 

• Early planning and FDA engagement are critical to defining acceptable study goals and timelines. 

• Investigators may overlook the fact that an approved device is still under observation—strong site training and monitoring is essential. 

• Data collection must be robust, follow-up consistent, and documentation flawless. 

• Any delays or protocol deviations must be proactively reported to avoid regulatory setbacks. 

At BioBoston Consulting, we understand the complexities of PAS implementation. Our experts help manage each step—from protocol development to final report submission—ensuring your post-market strategy remains fully compliant. 

 

Why Choose BioBoston Consulting for Your PAS Needs? 

At BioBoston Consulting, we provide end-to-end Post-Approval Study support for medical device manufacturers. Our team brings decades of regulatory and clinical operations expertise to ensure your PAS program is not only compliant but adds long-term value. 

We offer: 

• Customized PAS protocol design 

• Biostatistical planning and sample size justification 

• Site selection and training strategies 

• Data collection and case report form (CRF) design 

• FDA correspondence support 

• Interim and final PAS report drafting 

• Oversight of IRB and informed consent compliance 

Whether you are preparing for first-time PMA approval or need help managing ongoing PAS requirements, we are here to simplify the process. 

 

Let Us Take the Next Step Together 

Post-Approval Studies can be complex—but they do not have to be stressful. With the right partner, PAS compliance becomes a strategic advantage, not a burden. 

📩 Ready to strengthen your post-market compliance program?
Contact BioBoston Consulting today to learn how we can support your Post-Approval Study program from protocol to final submission.