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Zdrowie i gospodarka · 15.08.2014

Pilot Program for Qualification of Medical Device Development Tools

The Food and Drug Administration (FDA) is soliciting proposals to participate in a pilot program for Medical Device Development Tools (MDDT) qualification (MDDT Pilot Program). Under the MDDT Pilot Program, FDA intends to work together with developers of tools that meet the criteria for the proposed program, to determine whether certain tools may be developed and qualified in order to facilitate more predictable, efficient, and transparent regulatory evaluation when MDDTs are used to generate valid scientific evidence for medical device premarket applications.

Source: Federal Register — Food and Drug AdministrationOpen original release →