Integrating Clinical Evaluation Reports (CERs) into FDA Submissions: Best Practices and Pitfalls to Avoid

While Clinical Evaluation Reports (CERs) are traditionally linked to EU MDR compliance, an increasing number of medical device manufacturers are adopting CERs to strengthen their FDA submissions. This strategic integration helps deliver a cohesive and comprehensive clinical evidence package, aligning closely with FDA expectations and potentially expediting regulatory review timelines. 

 

The Role of CERs in FDA Regulatory Submissions 

Unlike the EU MDR, the FDA does not require a standalone CER as part of a 510(k), PMA, or De Novo submission. However, clinical evidence remains a cornerstone of FDA review, particularly for: 

• Novel devices lacking predicate devices 

• De Novo classification requests 

• High-risk medical devices 

• PMA supplements introducing new clinical safety data 

Manufacturers presenting a well-structured clinical evaluation can facilitate smoother FDA review and reduce the risk of additional information requests. 

 

Common Challenges When Incorporating CERs in FDA Submissions 

Many submissions falter due to avoidable errors related to clinical evidence such as: 

• Insufficient Clinical Data: Overly broad or unsystematic literature searches may incorporate irrelevant studies or miss critical clinical nuances, especially those specific to the U.S. patient population. 

• Misunderstanding Submission Types: Confusing submission pathways (510(k) vs. PMA vs. De Novo) can delay approval due to incomplete or inappropriate clinical data. 

• Unsubstantiated Clinical Claims: Claims unsupported by robust, traceable clinical evidence trigger scrutiny or outright rejection. 

• Neglecting Real-World Evidence (RWE): Data from registries, post-market surveillance, and adverse event databases often provide powerful support but are frequently underused. 

• Lack of Submission Integration: Inconsistent narratives between clinical data, risk assessments, and labeling sections create confusion during FDA review. 

 

Crafting a CER to Support FDA Submissions 

Although not mandatory, a well-prepared CER designed for FDA can be a valuable asset. Key considerations include: 

• Demonstrating data relevance for the U.S. patient population 

• Providing a clear and concise summary of clinical evidence, including published studies, registry analyses, and clinical trials 

• Performing thorough risk-benefit analyses linked directly to device labeling and intended use 

• Citing FDA-recognized standards and guidance documents such as 21 CFR 814 and the FDA’s Clinical Evidence Premarket Submission guidance 

 

Essential Resources for CER Development 

Efficient CER preparation depends on leveraging multiple authoritative data sources like: 

• FDA MAUDE Database for adverse event reports and comparative device safety insights 

• ClinicalTrials.gov to track ongoing and completed clinical studies 

• PubMed and Embase for accessing peer-reviewed clinical literature 

• FDA Guidance Documents to ensure alignment with evolving regulatory expectations 

• FDA CDRH Learn for updates on submission trends and requirements 

Harnessing these tools, combined with internal cross-functional collaboration and expert medical writing, optimizes clinical evidence presentation. 

 

How BioBoston Consulting Can Accelerate Your CER and FDA Submission Success 

Developing clinical evaluation reports tailored to FDA’s unique requirements demands specialized expertise and a strategic approach. At BioBoston Consulting, we provide comprehensive regulatory support to help manufacturers prepare submission-ready CERs that meet FDA expectations. We provide: 

• Expert clinical writers familiar with both FDA and EU regulatory frameworks 

• AI-assisted literature reviews and data extraction for efficiency and accuracy 

• Integration of FDA databases and current guidance directly into CER development 

• Rapid turnaround times for 510(k), PMA, and De Novo applications 

• Proven track record with a high first-time acceptance rate of clinical documents by FDA reviewers 

Whether you require a full CER, clinical gap analysis, or a targeted literature justification, BioBoston Consulting offers flexible, end-to-end solutions to optimize your regulatory strategy. 

 

Ready to Strengthen Your FDA Submission with Robust Clinical Evidence? 

Do not leave clinical evaluation to chance. Partner with BioBoston Consulting to ensure your clinical evidence is comprehensive, compliant, and compelling. Reach out today for expert guidance on integrating Clinical Evaluation Reports into your FDA regulatory submissions and accelerate your device’s path to market. 

Contact BioBoston Consulting now to get started!