ArticleNPJ digital medicine2024
Beyond the 510(k): The regulation of novel moderate-risk medical devices, intellectual property considerations, and innovation incentives in the FDA's De Novo pathway.
Article in NPJ digital medicine, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 24 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
24 citing papers in PubMed.
- A guide for the deployment, validation, and accreditation of clinical digital pathology tools.Journal of pathology informatics · 2026Article
- Fracture healing: from molecular and cellular mechanisms to therapeutic strategies.Signal transduction and targeted therapy · 2026Review
- Sensitivity of 510(k) medical device filings to government shutdowns: a brief communication.npj health systems · 2026Article
- Wearable Devices and Machine Learning in Cardiovascular Monitoring: Current Evidence and Future Directions for Precision Medicine.Journal of personalized medicine · 2026Review
- Advanced nanobiosensors for the detection of neurovascular damage in cerebral infarction: prospects and challenges.Journal of biological engineering · 2026Article
- Application of ultrasound and ultrasound-responsive materials in wounds: A systematic review.International journal of pharmaceutics: X · 2026Review
- Nature-Inspired Solutions: Biomimetic Materials and Adaptive Devices for Precision Urinary Oncology.Cancers · 2026Review
- 3D printing as an innovative tool in personalized management of complex airway diseases: a literature review.Journal of thoracic disease · 2026Review
- FDA-Approved AI Solutions in Dental Imaging: A Narrative Review of Applications, Evidence, and Outlook.International dental journal · 2026Review
- Microjoining for biomedical device fabrication: a perspective.Advanced materials joining · 2026Article
- The emergence of advanced technologies in the pharmacy profession and the need for education: The case of point-of-care sensing systems and 3D printing of pharmaceuticals.BioImpacts : BI · 2026Review
- Article
- Characterizing industry payments for FDA-approved AI medical devices.Health affairs scholar · 2025Article
- FDA-authorized software as a medical device in mental health: a perspective on evidence, device lineage, and regulatory challenges.Npj mental health research · 2025Article
- Trends in Industry-Sponsored Research Funding to Orthopaedic Surgeons in the U.S. from 2017-2024.medRxiv : the preprint server for health sciences · 2025Article
- Competitive value of acquiring novel FDA product codes for medical device manufacturers: an original investigation.npj health systems · 2025Article
- Reforming Food, Drug, and Nutraceutical Regulations to Improve Public Health and Reduce Healthcare Costs.Foods (Basel, Switzerland) · 2025Review
- Current Status and Future Directions in the Development of Digital Therapeutic Interventions for Neurodevelopmental Disorders.Clinical pharmacology and therapeutics · 2025Review
- The interplay between pulse width and activation depth in TENS: a computational study.Frontiers in pain research (Lausanne, Switzerland) · 2025Article
- Regulatory landscape of accelerated approval pathways for medical devices in the United States and the European Union.Frontiers in medical technology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
Abstract
Moderate-risk medical devices constitute 99% of those that have been regulated by the U.S. Food and Drug Administration (FDA) since it gained authority to regulate medical technology nearly five decades ago. This article presents an analysis of the interaction between the 510(k) process -the historically dominant path to market for most medical devices- and the De Novo pathway, a more recent alternative that targets more novel devices, including those involving new technologies, diagnostics, hardware, and software. The De Novo pathway holds significant potential for innovators seeking to define new categories of medical devices, as it represents a less burdensome approach than would have otherwise been needed historically. Moreover, it supports the FDA in its effort to modernize the long-established 510(k) pathway by promoting the availability of up-to-date device "predicates" upon which subsequent device applications can be based, reflecting positive spillovers that are likely to encourage manufacturers to adopt current state-of-the-art technologies and modern standards of safety and effectiveness. We analyze the of characteristics all the De Novo classification requests to date, including the submission type, trends, FDA review times, and device types. After characterizing how the De Novo process has been used over time, we discuss its unique challenges and opportunities with respect to medical device software and AI-enabled devices, including considerations for intellectual property, innovation, and competition economics.
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.