Evidence map›Paper›PMID 41879133›Full record

ReviewThe Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics2026

Medical Device Regulation - Who Does the FDA Serve?

Osman Moneer, Vinay Rathi

Abstract readReview
In one paragraph

Review in The Journal of law, medicine & ethics : a journal of the American Society of Law, Medicine & Ethics, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Osman MoneerDepartment of Medicine, https://ror.org/00f54p054Stanford University, United States.
Vinay RathiDepartment of Otolaryngology - Head & Neck Surgery, https://ror.org/00rs6vg23The Ohio State University College of Medicine, United States.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

Political pressures and institutional constraints have shaped a reactionary regulatory system that unduly preferences industry interests over public health. Breaking the reactive cycles that have long shaped device regulation will involve more than standard technical or incremental reforms. Congress would instead need to revisit more foundational values of device regulation to better align policy with the interests of patients and public health.

Indexed as

Device ApprovalEquipment and SuppliesGovernment RegulationMedical Device LegislationUnited States Food and Drug AdministrationHumansUnited States510(k)FDAMedical Device Regulation

Identifiers

PMID41879133
PMCPMC13053120

What Socratic holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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 Socratic graph.