EU & FDA IVD Regulatory Compliance
Rely on TE Connectivity to guide your project from design and validation all the way through regulatory approval and manufacturing scale up.
IVD manufacturers often get into trouble when they don’t adequately understand FDA or EU requirements for technical documentation in support of regulatory submissions. This can result in clinical data that is inadequate to support a successful FDA submission or EU Notified Body review. TE offers expertise in clinical research, usability testing, and regulatory compliance specifically for IVD devices. This can streamline market clearances for your medical device and ultimately get your device to market faster. With numerous successful 510(k), CLIA, EUA, and CE marking submission clearances under our belt, TE's proven experience lowers your project risk and improves the odds of a successful outcome.
Core Competencies
- Full Contract Research Organization (CRO) Studies
- FDA 510(k), De Novo, and CLIA Waiver Requirements for IVD
- FDA 510(k) and Premarket Approvals (PMA)
- EU MDR and IVDR Regulation Technical Documentation Requirements
- EU Post-Market Clinical Follow-Up (PMCF) Studies
- Medical Device Risk Management
- ISO 14155 (Clinical Investigations of Medical Devices)
FDA Clearance and Approval
The path to FDA clearance is not always a straight line. In the 510(k) pathway, the FDA relies on the concept of “substantial equivalence.” Basically this means they compare your device to another already cleared for sale. But what happens when your technology is novel? TE's in-house clinical and regulatory experts evaluate your technology, its intended use, and existing cleared devices to recommend a cost-effective regulatory strategy. We perform clinical research and human factors engineering (HFE) to expedite your IVD device studies by providing study design and planning in addition to statistical analysis and electronic data management. Our proven methods can shorten the overall time between design and FDA approval by months.
CE Marking and EU IVDR Compliance
The EU’s migration from the In Vitro Medical Devices Directive to the new In Vitro Diagnostic Regulation (IVDR) has dramatically changed the requirements for IVD manufacturers. Beginning in May 2022, nearly 85% of new IVDs will require CE Marking certification. TE has extensive knowledge of the new IVDR, especially as they relate to the clinical data requirements needed to support CE Marking certification of Class B, C, and D devices. We will help you navigate the new IVDR quagmire and help ensure that your technical documentation is ready for your eventual CE Marking certification audit by a European Notified Body.
IVD Regulatory Consulting for FDA Submissions
Several FDA regulatory submission pathways are available for IVDs, but the right choice is not always clear. What is clear is that going down the wrong path can cost your company a lot of money and significantly delay your market launch. We can help you get it right the first time.
How Long Will It Take? How Much Will It Cost?
The two most asked questions by clients, and for good reason! Answering them requires an experienced technical development team conversant in your specific IVD technology, paired with the regulatory expertise of a team that has advised dozens of IVD clients on FDA submissions. Our IVD Solutions team offers expertise in analytical, clinical, and usability studies in support of FDA submissions.
We Help Find the Optimal Path to FDA Clearance
We have worked with hundreds of IVD manufacturers and a wide variety of diagnostic technologies, including Point of Care (POC) tests, Over the Counter (OTC) devices and sophisticated diagnostic systems. We provide a variety of services including study design, protocol writing, pre-submissions, subject enrollment, data analysis to complete report for FDA submission.
In some cases, FDA feedback on study risk determination, proposed clinical trial protocols or other issues may be needed prior to submission. If needed, we will coordinate a formal pre-submission (pre-sub) advisory meeting with FDA reviewers to address those questions. Getting on the same page with FDA early on is the best way to avoid a Refuse to Accept (RTA) letter or a lengthy Additional Information (AI) request.
We Can Assist with these Clinical and Regulatory Services
Regulatory
FDA Device Classification
Submission Pathway Options
FDA Predicate Device Research
Dual 510(k) and CLIA Waiver
FDA De Novo Submission
FDA EUA to 510(k) Transition
Design Control and Design History Files
Clinical & Usability
Claims Review
Intended Use / Indications for Use
Investigational Device Exemptions (IDE)
Analytical Verification for 510(k)
Clinical & Stability Study Summary
Flex Studies
Usability Evaluation
In-House CRO Speeds Your Path to Approval
Our deep understanding of the clinical data needed to support specific types of IVD submissions allows us to design, develop and execute the most cost-effective study needed for a successful FDA 510(k), CLIA waiver, IDE or PMA submission.
