March 11, 2022
Proposed rule emphasizes a risk-based approach to quality management systems
On February 22, 2022, the Food and Drug Administration (FDA) published a proposed rule to amend the current good manufacturing practice (cGMP) requirements for medical devices under the Quality System (QS) regulation to harmonize with ISO 13485: 2016 Medical devices — Quality management systems — Requirements for regulatory purposes, the international consensus standard for medical devices. The intent of the proposed rule is to align FDA's regulatory framework with that used by other global regulatory authorities, promote consistency in the regulation of medical devices, and provide timelier introduction of safe, effective, high-quality devices to market.
Once finalized, the proposed rule will have significant impacts on risk management practices for medical device manufacturers, as ISO 13485 requires application of a risk-based approach in establishing and maintaining all aspects of a quality management system (QMS). Though FDA already expects risk management integration into a manufacturer's QMS over the total product life cycle currently, Part 820 explicitly addresses these activities only under the requirements for design controls in § 820.30(g).
It is anticipated that the harmonization will lead to greater systematic emphasis on risk management through the use of ISO 14971:2019 Medical devices — Application of risk management to medical devices. ISO 14971 provides risk management principles including those needed to identify, assess, and control risk, as well as monitor the effectiveness of that control.
In practice, device manufacturers may benefit by revisiting how their risk management practices interconnect with quality, design, manufacturing, and supply chain operations to ensure potential hazards are appropriately identified, quantified, and mitigated.
On March 2, 2022, FDA held a public meeting of the Device Good Manufacturing Practice Advisory Committee to discuss the requirements and potential impacts of this proposed amendment with industry and ISO stakeholders. Important questions and comments for consideration from the meeting included the following:
- If accepted, how will the updates to regulations be communicated across the industry?
- In addition to seminars, webinars, and training materials about ISO 13485 gap analyses, there should potentially be a multifaceted approach that leverages relations to other foundations of quality management such as ISO 9001.
- Training for FDA auditors would also be important to transition from existing audit techniques and requirements to new ones that aspire to assess conformity to ISO 13485.
- How can device manufacturers leverage their existing ISO 13485 certifications for compliance within the new U.S. regulatory landscape?
- One additional potential benefit not yet explicitly mentioned is how harmonizing the current U.S. regulatory landscape to those globally implemented may allow manufacturers to reallocate existing quality resources that are currently dedicated to global regulatory conformance toward improving R&D and public health.
- Smaller organizations or companies that are not specifically medical device manufacturers but contributed to producing goods and services during the pandemic can more readily set themselves up to be both a global provider and a U.S. provider with this harmonization.
- Will the current FDA Quality System Inspection Technique (QSIT) meet all the ISO 13485 inspection needs?
- How will the various types of FDA audits and inspections, such as pre-approval inspections, for-cause inspections, and compliance follow-ups, be affected by this transition?
- Is a one-year period sufficient for the proposed ruling to become effective after the date of publication?
How Exponent can help
Exponent's multidisciplinary team of biomedical engineers and regulatory consultants can help device manufacturers understand the nuances of FDA's new proposed regulatory framework and assist in drafting or reviewing submission packages. Our experts have extensive practical knowledge in various specialties required for regulatory submissions and can provide mechanical, chemical, and human factors testing as well as clinical value analyses, outcomes assessment, and data analytics for medical devices.