Zdrowie i gospodarka · 28.05.1999
Medical Devices; Draft Guidance on Quality Systems Inspections Technique; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance entitled ``Draft Guidance on Quality Systems Inspections Technique.'' This draft guidance is intended to provide FDA's field staff with a new inspectional method to assess medical device manufacturer's compliance with the quality system regulation (QSR), which became effective June 1, 1997. This draft guidance is also intended to represent the agency's current thinking on using a new inspectional technique, and it is neither final nor is it in effect at this time.