Pediatric Device Stakeholders

News & Events

FDA to Modernize 510(k) Program

FDA Commissioner, Scott Gottlieb, recently announced plans to update the FDA's 510(k) pathway for approving new medical devices.  The new plan emphasizes a need to be less reliant on older predicate technologies, and may publish when an applicant uses a predicate more than 10 years old.

"We believe that where appropriate, new medical devices that come to market under the 510(k) pathway should either account for advances in technology or demonstrate that they meet more modern safety and performance criteria."

Read the full press release here.


Links

Provides an overview of the FDA's PDC program, of which we are part

 

Provides guidance regarding device classification, basic regulatory requirements for approval, Quality System regulation, labeling requirements, and medical device reporting

 

 

Allows you to search the database of issued U.S. patents

 

       An institute based at the University of Pittsburgh with a primary focus of the development of technology to address tissue and organ insufficiency.

 

       A medical device development firm with a commercialization process focused on building value, risk reduction, design for manufacture, and shortening time to market.

 

A partner organization of the PPDC. NAMSA is a medical research organization providing expert regulatory, laboratory, clinical, and compliance services to medical device and healthcare product manufacturers. 

 

Provides information about the NIH Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, including opportunities to apply for federal funding to support small companies in research and development that has a strong potential for commercialization

 

  • To access the other Pediatric Device Consortia:

National Capital Consortium for Pediatric Device Innovation

Southwest National Pediatric Device Consortium

UCSF-Stanford Pediatric Device Consortium

Consortium for Technology and Innovation in Pediatrics