'Quik' Review Program Builds On US FDA eSubmission Efforts

The agency says 510(k)s submitted via an electronic template for any of about 40 product types might get a speedier review under a new pilot program.

train fast run on railway track in sunny day

US FDA is unveiling a new pilot program that will encourage companies to submit 510(k)s electronically with the promise of a quicker review time.

More from Regulation

FDA Scrubs ‘Gender’ From Final Guidance On Sex-Specific Data But Encourages More Women In Clinical Trials

 

The US FDA has published its final document to guide sponsors on using sex-specific data in designing clinical trials of medical devices. However, the guidance removes all references to gender that appeared in January’s draft guidance, released before the Trump administration took office.

HHS Has ‘Utterly Failed,’ Kennedy Advisor Argues

 
• By 

Calley Means defended reductions in force at the Health and Human Services Department that shocked and outraged federal workers and stakeholders.

Regulatory Experts Alarmed By Credible April Fool’s About US Targeting EU Notified Bodies

 

A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.

US Could Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

More from Policy & Regulation

Some Staff Say Makary’s First Speech To FDA Off-Target Despite Science Focus

 

Some employees were not impressed with FDA Commissioner Martin Makary's first speech to the agency staff, saying he did not seem to understand the agency's mission.

Swiss Blast US Import Tariffs As Medtechs Look For Dialog To Forestall Damage To Industry

 
• By 

Swiss medtech exporters seek urgent diplomatic action from the Swiss Federal Council in a bid to overturn the 2 April US decision to put tariffs on goods imports.

Democrats Condemn Trump’s HHS Layoffs During House Hearing On OTC Drug User Fees

 

Energy and Commerce Health Subcommittee Democrats focus on criticizing HHS Secretary Kennedy’s RIF announcement, including 3,500 FDA jobs among cuts across HHS agencies. Representatives were left wondering if user fee programs would continue, even if reauthorized.