In the third part of our article series on the FDA’s new “radical transparency” initiative, we explore strategic considerations for a successful 510(k) submission. As transparency and consistency become increasingly emphasized by the FDA, medical device manufacturers must approach their submissions with both thoroughness and coherence. Successfully navigating the FDA’s 510(k) pathway requires more than compiling test data. It necessitates strategic foresight, sound regulatory judgment, and a thorough understanding of the Agency’s evolving expectations. 

A strong 510(k) submission begins with selecting an appropriate predicate device with the same intended use and same/similar technological characteristics. Selecting a predicate device involves more than reviewing marketing claims. It requires a thorough review of FDA-cleared 510(k) summaries, potentially a FOIA request or other available information. For novel technologies or unconventional comparisons, a Pre-Submission (Q-Sub) meeting is strongly recommended to validate the approach and align expectations early.

The structure and consistency of the submission are equally critical. Particular attention should be paid to the Indications for Use statement, which must be identical across all sections of the submission. Inconsistencies in this area remain a leading cause of Refuse to Accept (RTA) decisions.

When referencing FDA-recognized consensus standards, do not merely list them but provide a rationale for their applicability. Any deviations from these standards must be justified with scientifically sound explanations and supported by appropriate validation data.

For devices incorporating user interfaces, human factors and usability engineering data, even when not explicitly required, can demonstrate a proactive approach to risk mitigation and patient safety.

Similarly, including data from failure mode testing, rather than only successful outcomes, strengthens the overall risk analysis and reflects a comprehensive understanding of device performance under stress conditions.

Where applicable, real-world evidence (RWE), such as post-market surveillance data or clinical experience from non-U.S. markets can further substantiate claims of safety and effectiveness.

Maintaining proactive engagement with the FDA throughout the process is highly beneficial. The Q-Sub program offers a valuable opportunity to obtain feedback on device classification, testing strategies, and regulatory pathways, while also fostering a collaborative relationship with the review team that can streamline the formal review process.

Internally, it is advisable to develop a submission reference guide in the structure of the eStar submission pdf. This is not for FDA review, but for internal use. This document outlines the logic of the submission, identifies the location of key data, and serves as a reference during FDA interactions.

Finally, don’t overlook the post-submission phase. Time your initial submission to avoid receiving FDA feedback during major holidays or vacation periods. Responding to Additional Information (AI) requests can be resource-intensive and time-sensitive. Failing to allocate sufficient personnel during this phase can lead to delays and missed deadlines.

The above practices represent a strategic and quality-driven approach to 510(k) submissions that position the sponsor for success in an increasingly transparent and data-driven regulatory environment.

Do you need support with your submission strategy or documentation? Let our team provide you with the insight and expertise that you need to achieve success.

 

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.