-
Americas
-
Asia & Oceania
-
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.
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
Regions
-
Americas
-
Asia & Oceania
-
Europe
-
Middle East & Africa
-
Americas
-
Asia & Oceania
-
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
SOLUTIONS
-
Life Sciences
-
Healthcare
Life Sciences
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.
Learn MoreLife Sciences
Healthcare
Accelerate digital innovation to enable smarter decisions that reduce cost, modernize patient and consumer engagement, and improve health outcomes.
Learn MoreHealthcare
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.
LEARN MOREBLOGS, WHITE PAPERS & CASE STUDIES
Explore our library of insights, thought leadership, and the latest topics & trends in healthcare.
DISCOVER INSIGHTS
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.