FDA and the US Department of Defense launched a program to prioritize development of medical products for use in the battlefield. The program implements recently enacted compromise legislation that resolved a turf battle between the two agencies.
Resolving an interagency turf battle, US FDA and the Department of Defense launched a program for FDA to give expedited review to medical products the DOD prioritizes as essential for military personnel.
The program implements H.R. 4374, which authorized the Secretary of Defense to request, and FDA to provide, expedited review of medical products intended to help save the lives of American...
Second submission window for joint scientific consultations on a procedure to help prepare for joint clinical assessments will open from 2 to 30 June 2025.
Speakers at a recent UK medtech outlook conference voiced optimism about the sector’s prospects, but warned that cost burdens, over-regulation and lengthy processes will impede the capacity of local SMEs to innovate. Only 10% of NHS procured medtech comes from UK manufacturers.
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
The FDA plans to announce class II status for four new device types, including tests for the Zika virus and genetic condition Fragile X. This follows earlier announcements and highlights a trend toward diagnostic classifications. The classifications are considered deregulatory, meaning they will hel
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry. The document introduces stakeholders to currently available resources for supporting their pre-subs to the agency.
During MD&M East in Manhattan last week, a panel of experts discussed how the Trump administration’s trade policy is affecting manufacturing and offered some ideas on what manufacturers can do to help mitigate the chaos.
