In a significant policy shift, the FDA has begun publishing Complete Response Letters (CRLs) for drug and biologic applications that were initially rejected but later approved. While this “radical transparency” currently applies only to pharmaceuticals, it may signal what’s ahead for medical devices.

As of July 2025, the U.S. Food and Drug Administration (FDA) has taken a significant step toward greater transparency by publishing more than 200 Complete Response Letters (CRLs) related to drug and biologic applications that were initially rejected but later approved. This move is part of a broader initiative that the agency refers to as “radical transparency”. By making these documents publicly accessible, the FDA hopes to foster a more informed and trustworthy regulatory environment.

Currently, this policy applies only to drugs and biologics. So far, the FDA has not announced any plans to include device-related rejection letters in this initiative. However, the agency has expressed continued interest in expanding its transparency efforts. If similar measures were introduced for medical devices, it would represent a major shift in regulatory disclosure practices.

The potential benefits of extending this transparency to medical devices could be that patients and healthcare professionals would gain valuable insights into why certain devices were not approved. This information could build trust in the regulatory process.

Increased transparency could also potentially accelerate innovation within the medical device industry. By highlighting common pitfalls in clinical trial design, data analysis, or device engineering, manufacturers could learn from the mistakes or shortcomings of others.

However, while the FDA’s move toward greater transparency aims to foster trust and accountability, it is not without potential drawbacks. Public disclosure of medical device rejection letters could lead to misinterpretation or sensationalism, particularly when complex regulatory decisions are oversimplified in media. There is also a risk of immediate reputational and financial damage, especially if rejections are made public before companies can manage the information.

Increased transparency may further expose proprietary strategies or perceived weaknesses, potentially benefiting competitors or triggering legal challenges. It could also add more pressure on regulatory teams, requiring more resources to prepare for potential public scrutiny. For smaller or early-stage companies, the fear of public failure could even discourage innovative submissions.

As the regulatory landscape shifts, companies must weigh these risks carefully and proactively prepare both their submissions and external communication strategies.

In the next part of this article series, we will explore how to Navigate the potential impact of “radical transparency”, ensuring that the FDAs move to greater transparency can be realized without undue harm to the industry.

Post-Market Surveillance (PMS) is more than complaint handling – it’s a strategic tool for patient safety, regulatory compliance, and continuous improvement. Under the EU MDR, a structured, proactive approach with strong links to risk management and authority dialogue is essential.

PMS has become a cornerstone of regulatory work under EU MDR 2017/745 and IVDR 2017/746. It’s not just about responding to incidents – it involves systematically and continuously collecting, analyzing, and acting on real-world data from medical device use, both from one’s own products and from competitors. The goal is to detect hidden risks, prevent recurring issues, and strengthen patient safety.

In my work with PMS and vigilance – both as a regulatory assessor at the Swedish Medical Products Agency (Läkemedelsverket) and as a consultant – I’ve seen how often PMS is mistaken for simple complaint handling. That’s a dangerous oversimplification. True PMS is integrated into the quality management system and requires collaboration with distributors, importers, and authorized representatives. Deficiencies in documentation, traceability, or training can lead to serious consequences, including recalls or regulatory intervention and, in the worst case, severe patient harm.

Five Common Pitfalls in PMS – and How to Avoid Them

1. Insufficient documentation and traceability:
   Missed safety signals can be costly. Establish clear processes for collecting, recording, and analyzing data.
2. Passive data collection:
   Don’t wait for incidents to arise. Be proactive – use (e.g. real-world information from healthcare professionals using the device), PMCF/PMPF studies, and market feedback.
3. Neglecting old products:
   Older products may develop new issues over time. Continue monitoring even years after market entry.
4. Lack of clear event investigation procedures:
   When something happens – gather all relevant information, including the affected product, determine the root cause, update the risk analysis, and implement CAPAs.
5. Poor communication and training:
   Your representatives, distributors, and resellers need the right knowledge to identify and report incidents in time.

Success Requires a Structured PMS Process:

• A clear plan for data collection, analysis, and reporting.
• Continuous monitoring of all products – including those already in use.
• Engagement in regulatory dialogues with authorities and notified bodies for quicker risk mitigation and transparency.
• Alignment with guidance documents such as MDCG 2023-3.
• Sufficient resources – with the option .

Final Note
PMS reflects an organization’s approach to quality. It’s about viewing issues as opportunities for learning and improvement – not as failures. An active and effective PMS system is not just a regulatory requirement; it’s essential to protect both patients and your company’s future.

Contact us to learn how we can support you with PMS strategy, documentation, training, and regulatory guidance – so you can focus on what matters most: safety.