FDA To Reject Device Test Firm’s Study Data, Cites Data Integrity

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

By signing up for a tour of the Thompson FDA Compliance Expert Suite, you are also registering to receive email offers and product updates from us. Simply click unsubscribe at the bottom of any email if you would like to discontinue delivery.

FDA Will Reject All Study Data From Device Testing Firm in China Due to Data Integrity Concerns

Dennis Tosh

March 12, 2025 at 01:17 PM EST

The FDA has determined that a Tianjin, China-based medical device testing company has “on several occasions” copied the results of another device study or created false or otherwise invalid data that was submitted to the agency. As a consequence, the FDA said in a Feb. 26 letter to the president of Mid-Link Technology Co. Ltd., until the company adequately addresses the data ... Read More

My Research Folders

You are not Logged in yet, Please login to see Your research folders.

Oops! Subscribers must be logged in to access this content.

Not A Thompson FDA Subscriber?

Unlock access to the benefits below with a no-cost, risk-free trial of the FDA Compliance Expert Suite.

Subscription Benefits

Start Your Free Trial

FDA Will Reject All Study Data From Device Testing Firm in China Due to Data Integrity Concerns

My Research Folders

THOMPSON FDA

COMPLIANCE EXPERT

RESOURCES

HELP

CONTACT