If At First You Don’t Succeed: VALID Act For Diagnostics Introduced In Congress For Third Time

The Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which calls for a new regulatory framework for diagnostic tests, has been reintroduced in the US Congress.

US Capitol.

Legislation that calls for a new regulatory framework for diagnostic tests has been introduced in the US Congress – for the third time.

The Verifying Accurate, Leading-edge IVCT Development (VALID) Act was reintroduced on 24 June by Sens. Richard Burr, R-NC, and...

Welcome to Medtech Insight

Create an account to read this article

More from Legislation

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

MDUFA VI Talks Begin with Familiar Priorities: Innovation, Transparency, Safety

 
• By 

At an Aug. 4 public meeting on MDUFA VI, FDA officials, industry representatives, and patient advocates outlined their priorities for the next user fee agreement, highlighting goals such as improved transparency, streamlined reviews, enhanced safety measures, and greater patient involvement.

Bipartisan Senate Bill Would Give Patients ‘True Price Tag’ Prior To Care

 

Pending legislation seeks to address what the sponsors argue is a lack of transparency in medical billing. If enacted, the bill would provide patients with the costs of procedures and medications before receiving them. A data collection expert discusses what the bill could mean for patients.

NHS Orders Halt On Unapproved AI Scribes, Vendors Rush To Self-Certify

 

NHS England's national chief clinical information officer issued a cease and desist on unapproved ambient voice technology and AI scribes. The move caused confusion among AVT vendors and went beyond joint MHRA/NHS guidance. IMed consultant Ben Austin shares his perspective.

More from Policy & Regulation

NAD Alerts Agendia Over Endorsing Physician’s Ties To Firm

 
• By 

The National Advertising Division (NAD) alerted Agendia to improve disclosure regarding a physician endorsing its MammaPrint test. The physician's ties to Agendia were inadequately revealed in LinkedIn posts.

FDA Ends Effort To Regulate LDTs By Rescinding Final Rule

 

Just a year and four months after publishing a final rule that would have allowed it to regulate laboratory developed tests as medical devices, the US FDA has rescinded the controversial measure, finally putting an end to the saga.

FDA Changes Fail To Diminish US Appeal To European Medtech Industry

 

Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.