Article Context:
FDA Proposal For 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 ISO 13485, which was released in 1996, was focused on the requirements for the implementation of quality management systems for the medical device industry. The second edition, which was released in 2003, focused on the requirements for the regulation of these systems. The third edition, which was released in 2016, added new features and improved the quality management systems’ compliance with the requirements of 21 CFR Part 820.
The FDA is proposing to incorporate the requirements of the International Organization for Quality Management Systems (ISO 13485) in its regulations for medical devices. This would help ensure that the systems are used properly and meet the requirements of the FDA. The agency noted that the requirements of the two regulations are generally in line with each other. After the convergence of the two, the regulations for medical devices would be similar. The agency is also proposing to accept the requirements of the ISO 13485:2016 without modifying them. It will also propose a requirement that would replace the existing requirement.
The FDA is not proposing to modify the requirements of 21 CFR Part 820 for establishments that manufacture finished devices. However, the agency noted that the legal authority to require these requirements exists for certain entities. The agency noted that the proposed amendments would only address the extent of the conflicts between the conflicting regulations.
The finished device is any component or accessory that can function seamlessly on its own regardless of its packaging or labeling. A manufacturer is anyone who designs, manufactures, or processes a finished device. Nonconformity is a term that refers to the failure of a manufacturing process or component to meet a certain requirement.Remanufacturers are those who modify or repackage a finished product to meet a specific requirement or improve its safety or performance. Rework is a process that involves taking a non-conforming product and performing a series of actions to ensure that it meets the requirements of the DMR. The validation process is a process that aims to establish that a manufacturing process consistently produces a finished product that meets its predetermined specifications.
Validation Process
The Validation Process is carried out by establishing that the specifications of a finished product conform with the intended use and user needs of the device. Human cell, tissue, or tissue-based products are also regulated as devices under this chapter. A customer is a person or organization that could receive or require a product or service from the manufacturer or another entity.
This requirement aims to place a greater emphasis on the development and implementation of risk management activities and procedures in the quality management system of device manufacturers. This process involves identifying, analyzing, and monitoring the various risks associated with the manufacturing of devices.
The FDA has proposed to establish a set of requirements for records that are subject to the requirements of ISO 13485:2016. The FDA is also proposing to establish requirements to ensure that the records related to the reporting of medical device complaints are captured. All firms that sell or manufacture medical devices are required to maintain records that contain the unique identification number (UDI) for each device. The retention of confidential records is also required under 21 CFR 820.180. These records can be marked to aid the FDA in determining if they should be disclosed.
The FDA proposes to strengthen the requirements for the labeling and packaging of medical devices under the International Organization for Standardization’s (ISO) 13485:2016 standard. This rule would also require manufacturers to regularly update their Quality Management Systems (QMS).
If the proposal is adopted, the FDA’s inspections will continue as usual. However, the agency would not issue certificates of conformity to ISO 13485. Instead, it would focus on ensuring that manufacturers comply with the requirements of the standard.