Zdrowie i gospodarka · 9.08.1999

Medical Devices; Global Harmonization Task Force: Summary Technical File Documents for Premarket Documentation of Conformity With Requirements for Medical Devices; Recommendations on the Role of Standards in the Assessment of Medical Devices; and a Recommendation on Medical Device Classification; Availability

The Food and Drug Administration (FDA) is announcing the availability of three documents entitled ``Summary Technical File for Premarket Documentation of Conformity With Requirements for Medical Devices;'' ``Recommendation: Role of Standards in the Assessment of Medical Devices;'' and ``Recommendation on Medical Devices Classification.'' Study group 1 of the Global Harmonization Task Force (GHTF) has prepared these documents on premarket regulation of medical devices. These documents are intended to provide information only and represent harmonized proposals and recommendations that may be used by governments developing or updating their premarket regulation schemes for medical devices. Elements of the approach set forth in these documents may not be consistent with current U. S. regulatory requirements. FDA is requesting comments on these documents.