February 25, 2022

FDA Proposal Set to Align Quality Systems Regulation With International Standards

The FDA has recently published a proposed regulation that will make its regulatory framework more closely aligned with the international framework used by other regulatory authorities around the world. If finalized, this amendment will further the FDA’s continued efforts to promote consistency in the regulation of devices and provide timelier introduction of safe, effective high-quality devices for patients.

Under the FDA’s current regulatory framework, medical device manufacturers are required to comply with the Current Good Manufacturing Practice (CGMP) regulations. These regulations provide for systems that assure proper design, monitoring and control of manufacturing processes and facilities. In other words, any company seeking to market a nonexempt, finished medical device in the United States is required to have a quality system in place for — among other things — the design, manufacture, packaging and labeling of the device. There are also requirements concerning data analysis to identify and correct potential quality problems.

The CGMP regulations have existed for more than two decades and were developed at a time when the FDA was just beginning to consider ways in which it could create a regulatory framework that is harmonious with other medical device regulators and the global industry. The FDA’s proposed regulation — which was introduced on February 23, 2022 — is a natural progression toward achieving this longstanding goal.

The FDA seeks to accomplish its goal primarily through the incorporation by reference of the 2016 edition of ISO 13485. ISO 13485 is used by many regulatory authorities around the world and is intended to help medical device manufacturers and others in the industry create a Quality Management System (QMS) that ensures the quality and safety of finished products. The standard provides a step-by-step framework for creating a QMS and evaluating gaps in an existing QMS.

The FDA’s proposed regulation also includes additional requirements to align with those already existing in the Federal Food, Drug and Cosmetic Act and makes edits to the Code of Federal Regulations (CFR) to clarify the device CGMP requirements for combination products.

This proposal has significant implications for manufacturers who seek to market their regulated medical products in the United States. The comment period for the proposed regulation ends on May 24, 2022. Comments may be submitted electronically through the Regulations.gov portal, or by mail or hand delivery. Instructions on how to submit comments are included under the Addresses section of the proposed regulation.

On March 2, 2022, the FDA will hold a public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee to provide information about the proposal and offer an opportunity to discuss the proposal’s requirements and potential impacts. The meeting, which is open to the public, will take place virtually from 9 a.m. to 6 p.m., Eastern Time. Links for attending the meeting can be found here. Interested persons may orally present data, information or views on issues pending before the committee. Those individuals interested in making formal oral presentations should follow the steps provided in the meeting notice.

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