FDA Issues Proposal To Amend The Medical Device Quality System Regulation
The FDA is proposing to modify the requirements of its Good Manufacturing Practices (cGMP) regulations to align them with the requirements of the ISO 13485:2016 standard for medical devices. The proposed amendments will affect the 21 CFR Part 4 regulation of combination products. They are part of the FDA’s efforts to align its regulations with the requirements of the international standard. The FDA aims to align its regulations with the requirements of other regulatory authorities in order to provide faster and more consistent access to safe and effective medical devices. FDA’s Requirement for Manufacturers The FDA’s requirement for manufacturers of medical devices to meet the requirements of 21 CFR Part 820 was first established in 1978. In 1997, the FDA added new design controls to the requirements for validating the safety and effectiveness of medical devices. The agency believed that this move would benefit the medical device industry and the public. ISO 13485 The first version of ...