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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
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- Hungary
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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
SOLUTIONS
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Life Sciences Solutions
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Healthcare Solutions
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Medical Device and Diagnostic
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U.S. Government
Life Sciences Solutions
Bringing together unparalleled healthcare data, advanced analytics, innovative technologies, and healthcare expertise to create intelligent connections that speed the development and commercialization of innovative medicines to improve patient lives.
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Healthcare Solutions
Accelerate digital innovation to enable smarter decisions that reduce cost, modernize patient and consumer engagement, and improve health outcomes.
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Medical Device and Diagnostic Solutions
Your world is unique – and quite different from pharma. In the U.S., decision-making has shifted from individual physicians to integrated networks--GPOs, IDNs and payers. These groups have heightened the focus on proving your solution’s value, demanding outcomes analyses and putting pressure on pricing.
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U.S. Government Solutions
For government agencies and organizations at every level—from federal or national to regional and local—Big Data can have a huge impact on public health.
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U.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.
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Get the latest insights on our life sciences, healthcare, and medical technology solutions in the United States. Follow our blog today!
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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.