explore -WSS

explore

author：focus 2025-09-01 06:01:11 - browse：66

Photography of the US department of health and human services in Silver Spring MD — Manuel Balce Ceneta/AP

An increasing number of medical device companies are submitting fabricated and unreliable data, the Food and Drug Administration noted Tuesday morning. The data comes from third-party labs hired by device firms to test the quality of their products.

Triple-check your data or we’ll reject your device, the FDA warned.

The goal of third-party testing is to ensure a device meets the FDA’s standards in a range of areas, including biocompatibility, sterility, and mechanical performance. The agency wrote that it has noticed an uptick in false data submissions in recent years, particularly from facilities based in China and India. In some cases, the facilities will send data copied from previous device submissions.

Get unlimited access to award-winning journalism and exclusive events.

Subscribe Log In

Previous article： Medical records are filled with copy
Next article： Pregnancy discrimination could be enabled by AI

WSS

As pharma fights Medicare drug negotiation, hospitals, docs silent

AstraZeneca bets AAV gene therapy will still deliver the goods

Winners, losers from Medicare’s list of drugs subject to price talks

Chemotherapy shortages won’t get better under Biden’s latest plan

Teach medical students about patients with intellectual disabilities

Roche to buy Carmot Therapeutics, developer of obesity drugs

hotspot

explore

knowledge

Wildfire smoke exposes gaps in outdoor worker protections

Pfizer plans to depart BIO

Drug repurposing or repositioning? The language matters

STAT letters to the editor on burnt

The high cost of giving birth even with insurance

2024 GOP presidential candidates spar over abortion in debate

Medical records are filled with copy

Complete sequence of Y chromosome published for first time

What does generative AI mean for health care? We asked experts

FDA needs staff influx to meet gene therapy needs, Marks says

focus

Teach medical students about patients with intellectual disabilities

SCOTUS to consider access to abortion pill mifepristone

What AAP's gender

Chemotherapy shortages won’t get better under Biden’s latest plan

Pfizer plans to depart BIO

AI models in health care face new federal disclosure requirements

focus

knowledge

hotspot

knowledge