According to an updated guidance on FDA’s eCopy submission program, it now accepts a broader range of PDFs. The update contains expanded guidelines for industry when submitting electronic versions of applications to FDA.
FDA updated guidance on its eCopy program for medical device submissions Oct. 10 to clarify its proper usage to help companies submit electronic versions of device applications to the agency.
The revised guidance contains some substantive changes and adds clarifications and additional instructions to the previous final guidance issued on Dec. 31, 2012. (See Also see "FDA...
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
The US FDA says its updated draft guidance represents one of several steps the agency is taking to develop electronic submission templates for the medical device industry.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.
