1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Legislation

Software Pre-Certification Program Highlights Needs For Legislative Change, FDA Says

 
• By Hannah Daniel

In a report published September 26, the FDA released the findings from its software pre-certification program which include the need for a new regulatory authority to supplement current regulations for medical devices.

• Source: Shutterstock

Software used as a medical device (SaMD) needs a new regulatory authority that would require legislative change, the Food and Drug Administration reports in a new document detailing findings from its 2017 Software Pre-Certification program.

The new authority would not replace the current regulatory framework. Instead, it provides supplementary guidelines to keep up with a...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Legislation

CMS Announces $50B In Grants For Rural Health Transformation

AdvaMed has praised CMS’ Rural Health Transformation Program, which will allocate $50 billion over five years to enhance rural healthcare. States can apply for grants by Nov. 5 to develop sustainable healthcare systems and improve patient outcomes.

PathAI Expands AISight Dx Label With PCCP-Guided Addition Of Roche Scanners

 
• By Natasha Barrow

Roche’s scanners have been integrated with PathAI’s AISight Dx system. The system’s FDA-cleared PCCP allows new components to be validated and integrated without additional FDA clearance. Eric Walk, chief medical officer, hints at future biopharma companion diagnostic collaborations.

NextGen Dx Panel Expects Continued Limbo On LDT Regulation

 
• By Elizabeth Orr

A recent conference panel discussed the stagnation in diagnostics regulation, highlighting the FDA's failed regulatory efforts on lab-developed tests. Political and legislative challenges hinder other reforms, and concerns over Medicare reimbursement cuts loom for the clinical lab industry.

No EUDAMED, No Market: ‘Waiting Until Mandatory Deadline Is Risky’

 
• By Natasha Barrow

EirMed CEO Richard Houlihan warns that EUDAMED (the European database on medical devices) publication delays may harm medical device manufacturers. Currently, only a fraction of the required uploads have occurred, creating potential compliance risks as the mandatory deadline approaches.

More from Policy & Regulation

FDA Oversight Still Falling Short on Women’s Safety, Advocate Finds

 
• By Elizabeth Orr

Device safety advocate Michelle Llamas says the FDA’s device review system leaves women at risk, citing weak oversight of 510(k) clearances, delayed safety warnings, and underrepresentation in trials. Her updated report urges stronger monitoring, transparency, and safeguards.

Have Your Say On EU Digital Regulation Overkill

 
• By Amanda Maxwell

European Commission is expected to have tsunami of responses, including from medtech stakeholders to its public consultation. The US is already intensely interested in developments.

Pair Of Safety Alerts In Line With Broader FDA Enforcement Crackdown

 
• By Brian Bossetta

The US FDA issued two safety alerts concerning associated risks from unauthorized medical devices. The alerts are consistent with a larger effort to clamp down on consumer goods that have not been subject to agency review.