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Americas
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Asia & Oceania
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A-I
J-Z
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
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Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
Regions
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Americas
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Asia & Oceania
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Europe
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Middle East & Africa
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Americas
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Asia & Oceania
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Europe
Europe
- Adriatic
- Belgium
- Bulgaria
- Czech Republic
- Deutschland
- España
- France
- Greece
- Hungary
- Ireland
- Israel
- Italia
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more -
Middle East & Africa
EMEA Thought Leadership
Developing IQVIA’s positions on key trends in the pharma and life sciences industries, with a focus on EMEA.
Learn more
WHO WE HELP
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Pharmaceutical Manufacturers
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Emerging Biopharma
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MedTech
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Financial Institutions
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Government and Public Health
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Health Plans
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Hospital and Health Systems
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Insurers and Risk
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Medical Specialty and Patient Advocacy
Pharmaceutical Manufacturers
Harness unparalleled healthcare data, advanced analytics, and cutting-edge technologies with our expertise to accelerate the development and commercialization of innovative medicines, enhancing patient lives.
Discover MorePharmaceutical Manufacturers
Emerging Biopharma (Global page)
Boost your innovation with IQVIA's expert team. Our comprehensive solutions integrate top-tier insights, technology, and expertise to maximize your asset's success in a competitive landscape.
Discover InnovationsMedTech
Navigating MedTech's unique landscape: U.S. decision-making now rests with GPOs, IDNs, and payers, who demand solid value proof through rigorous outcomes analyses and pricing scrutiny.
Explore MedTechMedTech
Financial Institutions
Invest in healthcare with confidence. Stay ahead of pharma and medical device trends using real-time, high-quality data. Access market insights, historical sales, prescription trends, and emerging product information for informed, risk-reduced decisions.
Access InsightsGovernment and Public Health
Unlock deeper health insights with unmatched data and innovative technology to enhance decision-making for your essential government programs.
Unlock InnovationsGovernment and Public Health
Health Plans
Accelerate digital innovation with our data-driven expertise in data science and healthcare, optimizing business processes for smarter decisions.
Navigate Health PlansHospital and Health Systems
Leverage digital innovation to cut costs, boost efficiency, and elevate patient engagement, all while enhancing quality and health outcomes.
Streamline DecisionsHospital and Health Systems
Insurers and Risk
Enhance your ability to evaluate and forecast population risk swiftly and accurately by integrating unmatched data, expertise, and technology.
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Medical Specialty and Patient Advocacy
Transform into a data-driven organization that enhances your specialty and showcases value to your members through digital transformation.
Explore NowU.S. PROGRESS POINT
A curation of IQVIA's best thinking on topics and trends driving change, disruption, and progress in the United States healthcare market.
LEARN MOREBLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
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PODCASTS
"Discover the future through our enlightening podcasts available in the United States.
EXPLORE PODCASTS
Fact Sheet
Making the Most of FDA's De Novo Classification Program
Medical devices and in vitro diagnostics
Sep 05, 2018
For companies looking to launch a novel, low-to-moderate risk medical device, the traditional pre-market notification 510(k) submission pathway may not be an option if no comparable (also known as ‘predicate’) device already exists in the market.
Legislation, passed and implemented in 1997, refined in 2012 and further clarified in the FDA’s 2017 guidance, now permits the FDA to streamline the classification process under the appropriate level of regulation based on the novel device’s risk profile.