Articlenpj health systems2025
Competitive value of acquiring novel FDA product codes for medical device manufacturers: an original investigation.
Article in npj health systems, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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
0 citing papers in PubMed.
No citing paper in PubMed yet.
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
No grant is acknowledged in the PubMed record.
Abstract
The FDA classifies medical devices by risk, assigning each a product code (PC) that determines its regulatory pathway for clearance. Novel PCs are created when new technologies raise safety or efficacy questions not addressed by existing codes. This analysis examines whether novel PCs provide strategic or regulatory advantages to first-mover manufacturers and how PC use evolves. Using FDA clearance data from 2000-2024, we analyzed the origin, usage patterns, and review timelines of novel PCs across filing types and specialties. We find that initial filers of novel PCs often experience a delay before reuse, suggesting a period of de facto exclusivity. This exclusivity varies by pathway: traditional 510(k), PMA, and Post-NSE De Novo filings are associated with longer exclusivity periods, while Direct De Novo filings offer shorter windows and longer review times despite producing most novel PCs. These trends indicate acquiring novel PCs may benefit manufacturers across risk classes and specialties.
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.