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Zdrowie i gospodarka · 18.08.2015

Pilot Program for Medical Device Reporting on Malfunctions

The Food and Drug Administration (FDA) is soliciting nominations for participation in a pilot program for the submission of medical device reports for malfunctions of class I devices and certain class II devices in summary format on a quarterly basis. Under the Medical Device Reporting on Malfunctions pilot program, FDA intends to work with manufacturers to identify candidates for the pilot program and intends to continue to accept nominations until candidates for the pilot program have been selected.

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