In the second part of our article series on the FDA’s new “radical transparency” initiative, we explore regulatory strategies to navigate the potential impact of this evolving approach. Importantly, the same strategies that help mitigate risks under increased transparency also serve to strengthen the likelihood of a successful submission.

Given the FDA’s growing emphasis on transparency and the potential public disclosure of medical device rejection letters, companies must adopt a more proactive regulatory strategy. This evolution underscores the necessity not only to comply with regulatory standards but also to prepare for the public scrutiny of negative outcomes. Companies should operate under the assumption that rejection letters may eventually be disclosed and develop their communication strategies with this in mind. For example, companies should refrain from making exaggerated claims in marketing or investor communications that could later be contradicted by FDA feedback. A trustworthy and transparent approach is essential for maintaining credibility with both regulators and stakeholders.

However, the primary and most effective approach is to enhance submission quality. Clinical evidence must be robust, characterized by sound methodology and meaningful endpoints. It is crucial to address safety and efficacy comprehensively. By anticipating FDA concerns and addressing them clearly within the submission, companies can save time and avoid the need for rework. Well-structured, concise documentation facilitates efficient review, making it easier for reviewers to understand the device’s benefits and risks.

Early engagement with the FDA is also increasingly important. Use Pre-Submission (Pre-Sub) meetings to clarify expectations and get feedback before formal submission. If applicable, programs like Breakthrough Devices or Safer Technologies Program (STeP) can offer further support and guidance.

Staying updated on guidance documents and policy changes is essential. Regulatory expertise is central to this process. Whether through in-house teams or external consultants, experienced professionals who are well-versed in FDA expectations can provide invaluable guidance for submissions and help interpret evolving regulations. This expertise ensures that submissions are aligned with the latest standards and reduces the risk of non-compliance.

Finally, ensure you have a clear plan in place for how to respond to a rejection, revise the submission, and manage communications. Evaluating alternative regulatory pathways such as 510(k), De Novo, or PMA can also provide flexibility.

Given the complexities of regulatory compliance and the evolving landscape of FDA transparency, having a robust regulatory strategy is more crucial than ever. Our team of experienced professionals can support your regulatory efforts to ensure compliance, mitigate risks, and safeguard long-term business continuity. Feel free to reach out to discuss how we can assist you in navigating these challenges effectively.

In the next part of this article series, we will look at some Strategic Considerations for a Successful 510(k) Submission.

 

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.

 

ISO 10993-1, the core standard for the biological evaluation of medical devices, has been under revision over the past few years. A Final Draft International Standard (FDIS) was published earlier this spring, and the voting was closed the July 17. The standard was approved and is now under publication.

What’s changing?

The new version of ISO 10993-1 strengthens the alignment between biological evaluation and risk management principles.

Key changes include:

  • Closer integration with the risk management process as defined in ISO 14971. The biological evaluation is now more explicitly linked to the stages of the risk management process.
  • A revised method for calculating total exposure, focusing on the number of days from first to last exposure, rather than total contact time.
  • The table in former Annex A covering biological endpoints is replaced by several smaller tables integrated into the main text. The term biological endpoint is replaced by the term biological effect. The tables list which effects to consider for different types of device contact (intact skin, mucosal membranes, internal tissues, circulating blood). Notably, material-mediated pyrogenicity is no longer listed as a biological effect in any of these tables.
  • New requirements for the Biological Evaluation Plan, which should include or reference criteria for the acceptability of specific biological risks associated with the medical device.
  • A new annex with guidance on characterization

What does this mean for you as a manufacturer?

Manufacturers will be expected to apply the new version whenever a biological evaluation needs to be updated (for example, due to changes in the device design, materials, or manufacturing process).

To prepare, we recommend performing a gap analysis of your current biological evaluations against the new standard. In particular, consider the following:

  • Does the revised method for calculating total exposure change which biological effects you need to evaluate? If so, plan ahead to ensure future compliance.
  • Do your SOPs and templates for biological evaluation need to be updated? If yes, take steps to align them with the new requirements.

How we can support you

At Aurevia (formerly QAdvis), we closely monitor regulatory developments and help our clients stay ahead of changes. We offer:

  • Gap analyses and documentation reviews
  • Support in updating biological evaluations

Want to know more?

Feel free to reach out if you’d like to discuss how the upcoming version of ISO 10993-1 may affect your products and documentation. We’re here to help you stay compliant, informed, and ready.

 

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.