Medical Devices; Quality System Regulation Amendments

2 organizations filed 2 public comments on Medical Devices; Quality System Regulation Amendments, at the Food and Drug Administration. The comment window closed 1526d ago.

Abstract

The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by converging with the quality management system (QMS) requirements used by other regulatory authorities from other jurisdictions (i.e., other countries).

Commenters (2)

• Advanced Medical Technology Associationtrade assoc.

  1 filing · confidence 97%
• Consumer Healthcare Products Associationtrade assoc.

  1 filing · confidence 97%