QMSR: the FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485 explained
The ISO 13485 vs 21 CFR 820 binary has posed a key quality challenge for American medical device manufacturers for a long time. But now that challenge looks to be breaking down.
The United State Federal Drug Administration (FDA) recently presented its Quality Management System Regulation or QMSR, harmonizing FDA 21 CFR 820 with ISO 13485:2016, to the White House for approval.
FDA 21 CFR 820 is a widely adopted regulation that structures the quality management systems of thousands of American medical device manufacturers.
But it's also over 25 years old.
By using the QMSR to bring in elements of ISO 13485 (the international medical device quality management standard in the 8th year of its current revision), the FDA hopes to freshen up its medical device quality requirements and harmonize them with the more recent cGMP expectations of international authorities. Here's what you need to know about the FDA QMSR.
The FDA QMSR harmonizes 21 CFR Part 820 and ISO 13485
When it launched in 1997, FDA 21 CFR Part 820 borrowed from many aspects of ISO 13485:1996, but it hasn't kept pace with ISO's medical device QMS regulatory requirements since then.
The FDA has been planning to get back into lockstep with ISO 13485:2016 since 2018, but the complexity of the QMSR project coupled with the impact of COVID-19 has delayed the harmonization drive.
Even though the QMSR is set for publication in early 2024, FDA investigators and auditors will need to be retrained, the Quality System Inspection Technique (QSIT) refreshed, and a string of agency guidance documents updated. So we can expect many more months of transition before 21 CFR Part 820 and ISO 13485 are aligned and the QMSR goes live.
International harmonization is a good thing
The synchronization of FDA and ISO requirements with the FDA QMSR can only be a positive for medical device manufacturers both inside and outside the US.
The proposed QMSR will help organizations meet the demands of both bodies, and the global harmonization work already seen with initiatives like the MDSAP can take a step further to full international regulatory alignment.
Not only that, the FDA has acknowledged that ISO 13485 offers a stronger framework for medical device quality management than 21 CFR 820 currently provides.
The link between ISO 13485 and ISO 14971, for instance, provides deeper risk management guidance. And the FDA points to multiple ISO 13485 quality systems principles, which are more robust than their current regulation.
In short, the QMSR will ask US medical device manufacturers to do more than they currently do - making expansion overseas much easier as a result.
ISO 13485 vs. 21 CFR 820
Ahead of the FDA's QMSR plans, you may want to refresh yourself with the current differences in the layout and structure of ISO 13485 vs. 21 CFR 820.
Comparing ISO 13485 vs 21 CFR 820 is the first step to understanding the current differences between the two standards, and - crucially - understanding which of those differences will be eroded and resolved by the QMSR harmonization plan.
| FDA 21 CFR Part 820 | ISO 13485:2016 |
| § 820.1 - Scope |
1 Scope 2 Normative References |
| § 820.3 - Definitions | 3 Terms and Definitions |
| § 820.5 - Quality system |
4 Quality Management System 4.1 General Requirements 4.2 Documentation Requirements |
| § 820.20 - Management responsibility | 5.0 Management Responsibility |
| § 820.22 - Quality audit | 8.2.4 Internal Quality Audits |
| § 820.25 - Personnel | 6 Resource Management |
| § 820.30 - Design controls |
7.1 Planning of Product Realization 7.2.1 Customer Related Processes 7.2.2 Review of Requirements Related to Product 7.3 Design and Development |
| § 820.40 - Document controls | 4.2.4 Control of Documents |
| § 820.50 - Purchasing controls |
7.4.1 Purchasing Process 7.4.2 Purchasing Information 7.4.3 Verification of Purchased Product |
| § 820.60 - Identification |
7.5.8 Identification |
| § 820.65 - Traceability |
7.5.9 Traceability |
| § 820.70 - Production and process controls |
6.2 Human Resources 6.3 Infrastructure 6.4 Work Environment and Contamination Control 7.5.1 Control of Production and Service Provision 7.5.6 Validation of Processes for Production and S ervice Provision |
| § 820.72 - Inspection, measuring and test equipment |
7.6 Control of Monitoring and Measurement Equipment |
| § 820.75 - Process validation |
7.5.6 Validation of Production and Service Provision |
| § 820.80 - Receiving, in-process, and finished device acceptance |
7.1 Planning of Product Realization 7.4.3 Verification of Purchased Product 7.5.1 Control of Production and Service Provision |
| § 820.86 - Acceptance status |
7.5.8 Identification |
| § 820.90 - Nonconforming product |
8.3 Control of Nonconforming Product |
| § 820.100 - Corrective and preventive action |
8.5.2 Corrective Action 8.5.3 Preventative Action |
| § 820.120 - Device labeling |
4.2.3 Medical Device File 7.5.8 Identification 7.5.11 Preservation of Product |
| § 820.130 - Device packaging |
4.2.3 Medical Device File 7.5.8 Identification 7.5.11 Preservation of Product |
|
§ 820.140/50/60/70 - Handling/ Storage/Distribution/ Installation |
4.2.3 Medical Device File 7.1 Planning of Product Realization 7.5.8 Identification 7.5.11 Preservation of Product |
| § 820.180 - General requirements |
4.2 Documentation Requirements 4.2.3 Medical Device File 7.1 Planning of Product Realization |
| § 820.181 - Device master record |
4.2.3 Medical Device File |
| § 820.184 - Device history record |
4.2.5 Control Records 7.1 Planning of Product Realization 7.5.8 Identification |
| § 820.186 - Quality system record |
4.2 Documentation Requirements 7.1 Planning of Product Realization |
| § 820.198 - Complaint files |
7.2.3 Communication 8.2.1 Feedback 8.2.2 Complaint Handling 8.2.3 Reporting to Regulatory Authorities |
| § 820.200 - Servicing |
4.2.3 Medical Device File 7.1 Planning of Product Realization 7.5.4 Servicing 7.5.8 Identification |
| § 820.250 - Statistical techniques |
8.1 General 8.4 Analysis of Data |
Preparing for the QMSR alignment of 21 CFR Part 820 and ISO 13485
On March 2, 2022, the FDA held a session of the Device Good Manufacturing Practice Advisory Committee to present and discuss the harmonization of 21 CFR Part 820 and ISO 13485 with the QMSR. This day heralded a new chapter of stronger, deeper and more internationally converged regulatory guidance for medical device quality professionals.
Stay tuned for more news, now that the QMSR has been finalized and presented to the White House for approval and review. And while you wait, take a look at the other key differences between FDA Title 21 and international medical device regulations.
