FDA Regulatory Consulting & Submission Support

Medical device FDA regulatory consulting and submission support

Partner with therapy-focused FDA regulatory consultants who know how medical devices, diagnostics, and digital health technologies are evaluated. IQVIA MedTech delivers strategic and operational support across 510(k), De Novo, PMA, IDE, and Breakthrough pathways—helping you manage regulatory complexity, strengthen submissions, and prepare for market entry.
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FDA guidance across every stage of MedTech development

Bringing together regulatory expertise, therapeutic specialization, and integrated MedTech capabilities, IQVIA MedTech helps medical device companies navigate FDA pathways—from early development and regulatory planning through FDA engagement, submission support, and post-market compliance. Our teams connect regulatory, clinical, quality, and market access considerations to help simplify complexity and support informed decisions throughout the product lifecycle.

Breakthrough Device Designation Consulting
Strategic support for medical device manufacturers seeking FDA Breakthrough Device Designation. With over 100 successful Breakthrough Device submissions, we help assess eligibility, develop designation requests, and prepare engagement strategies for FDA interactions throughout development.

Breakthrough Device Designation Consulting

Investigational Device Exemption (IDE) Submission
Regulatory strategy and submission support for IDE applications, including positioning preclinical testing for your product to get IDE approval, study design considerations, FDA interaction management, and clinical evidence planning to support investigational device studies in the United States.

Investigational Device Exemption (IDE) Submission

De Novo Classification
After getting over a dozen de novo’s granted, we provide expert guidance for novel medical devices without a predicate device, establishing appropriate classification pathways, developing regulatory strategies, strategizing special controls, and preparing De Novo submissions for FDA review.

De Novo Classification

510(k) Submissions
By getting hundreds of 510(k)s cleared, we provide complete support for establishing a predicate pathway, thorough substantial equivalence arguments that lead to market clearance for your traditional, abbreviated, and special 510(k) submissions.

510(k) Submissions

Premarket Approval (PMA)
With over 60 PMA approvals across all therapies, we provide end-to-end regulatory strategy, scientific review, and compliance advisory for high-risk Class III devices requiring rigorous safety and effectiveness data.

Premarket Approval (PMA)

Explore our US FDA regulatory services

Leverage the expertise of our specialized FDA consultant medical device team to manage complex submissions and strategic regulatory affairs consulting. We actively advise and implement robust strategies across the entire submission lifecycle.

Our proven performance

Our metrics reflect decades of leadership in overcoming complex U.S. regulatory barriers for medical device manufacturers — and an unparalleled track record of successful PMA approvals, breakthrough designations, and challenging 510(k) clearances.

100%

PMA Approval Rate

100+

Breakthrough Device Designations

500+

510(k) Clearances

65+

PMA Approvals

15+

De Novo Authorizations

5

FDA Advisory Panel Meetings Supported

MCRA IS NOW PART OF IQVIA MEDTECH
Trusted FDA Expertise. Expanded Global Capabilities.
MCRA's longstanding FDA regulatory expertise and deep understanding of the evolving regulatory landscape are now backed by IQVIA MedTech's global clinical, data, market access, and commercialization capabilities, helping medtech innovators navigate critical milestones across the product lifecycle.
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The path to PMA

Helping Empirical Spine navigate and win FDA premarket approval (PMA)

THERAPY
Spine


SERVICES
U.S. Regulatory, Clinical, Biocompatibility & Safety Management

Empirical Spine is the manufacturer of the LimiFlex Dynamic Sagittal Tether, a novel implant intended to provide flexion-restricting stabilization of the spine following lumbar decompression. They approached MCRA, an IQVIA Business, prior to study enrollment for regulatory strategy and clinical study support.
Challenge

Empirical Spine needed assistance with all IDE regulatory activities, breakthrough device designation, CEC management, clinical trial support, modular PMA submission, and related FDA interactions.
They leveraged our integrated U.S. Regulatory, Biocompatibility, Safety Management, and Clinical teams to provide comprehensive strategy and support to guide them through their IDE and PMA journey.
Solution

MCRA’s regulatory team served as a strategic partner to Empirical Spine, bringing in experts in biocompatibility, safety management, clinical research, quality assurance, and other subject-matter areas as needed — and enabling the lean Empirical Spine team to get the right support when it mattered most.

“MCRA has been our partner on this PMA since the beginning of the trial. From clinical trial enrollment, including through COVID, to our modular PMA submission process, MCRA’s insight and relationships with the FDA review team were key to our regulatory strategy and success.”

— Louie Fielding
Co-Founder and COO at Empirical Spine

Results

MCRA’s extensive expertise in spinal devices, combined with its integrated service offerings, led to a successful PMA for the LimiFlex Dynamic Sagittal Tether.

“MCRA’s integrated team of experts allowed us to be the right partner for Empirical Spine throughout their IDE and PMA journey. By giving them access to our deep bench of specialists exactly when they needed it, we helped them navigate the most complex regulatory pathway in the U.S. for medical devices, while enabling them to maintain a lean and efficient sponsor team. It is especially rewarding to help small companies bring meaningful innovation to patients, and Empirical Spine’s success is a testament to that mission.”

— Margeaux Rogers
Vice President, Regulatory Affairs at MCRA, an IQVIA business

Therapeutic and device specialization powering MedTech regulatory consulting
We strengthen regulatory strategy for medical devices through integrated clinical, quality assurance and reimbursement expertise. We align therapeutic insight, device science, and global regulatory requirements to design clinical strategies that generate robust, submission‑ready evidence—supporting predictable regulatory outcomes across 15+ therapeutic areas. Our teams understand how regulators evaluate medical devices—translating regulatory expectations into programs that are compliant, efficient, and purpose‑built to support approvals, clearances, certifications, and expansions.
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Frequently asked questions about FDA regulatory consulting

We combine deep regulatory intelligence with scientific discipline. Our integrated team analyzes your product's design, clinical data, and target claims early in the lifecycle to construct an optimal pathway, avoiding costly submission deficiencies and formatting errors.
Yes. Our consultants have a proven track record in navigating FDA appeals and complex regulatory disputes. We analyze the FDA's scientific objections and formulate robust, data-backed remediation plans to re-engage agencies effectively.
Developing a regulatory strategy in isolation can lead to clinical trials that fail to collect necessary endpoints for insurance coverage or market adoption. Our cross-disciplinary approach helps align your FDA clinical evidence with regulatory, safety, and reimbursement requirements simultaneously.

Yes. We provide comprehensive FDA Advisory Panel support, helping medical device and diagnostic companies prepare for every stage of the panel process. Our team develops panel strategies, presentation materials, executive talking points, and response scripts, and conducts realistic mock panel rehearsals designed to replicate the FDA advisory panel environment.

We can support expert identification and coordination, manage audiovisual and logistics planning, and help prepare company representatives for panel questioning. Our team has extensive experience presenting directly to the FDA on behalf of clients and guiding organizations through high-stakes regulatory milestones, including PMA and other complex submissions requiring advisory panel review.

Join the list of innovators who trust IQVIA MedTech to navigate the FDA
From breakthrough device designations to complex biologics submissions, we help you launch with confidence.
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