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.