The FDA's plans to harmonize FDA 21 CFR Part 820 and ISO 13485

The FDA plans to present a draft revision of its Quality System Regulation, FDA 21 CFR 820, that brings it into harmony with ISO 13485:2016.

FDA 21 CFR 820 is a widely adopted regulation that structures the quality management systems of thousands of American medical device companies.

But it is also almost 25 years old.

By bringing in elements of ISO 13485, the medical device quality management standard in the 6th year of its current revision, the FDA hopes to freshen up 21 CFR 820 and harmonize it with the more recent cGMP expectations of international authorities.

Here's what we know so far.

 

 

1. The big day: March 2

 

The FDA will hold a session of the Device Good Manufacturing Practice Advisory Committee on March 2, 2022 to present and discuss the harmonization proposal.

The session will run from 9am to 6pm EST and is open to the public, should you wish to join.

 

2. It's been a long time coming

 

When it launched in 1997, FDA 21 CFR Part 820 did borrow from many aspects of ISO 13485:1996 - but hasn't kept pace with ISO's medical device QMS regulatory changes since then.

The FDA has been planning to get back into lockstep with ISO 13485:2016 since 2018, but the complexity of the project coupled with the impact of COVID-19 has delayed the harmonization drive.

FDA investigators and auditors will need to be retrained, the Quality System Inspection Technique (QSIT) refreshed and a string of agency guidance documents updated if the project does go ahead, so we can expect many more months of transition before the update goes live.

 

3. International harmony? Bring it on

 

The synchronization of FDA and ISO requirements can only be a good thing for medical device quality professionals.

For a start, organizations will naturally find it easier to 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 QMS principles which are 'more robust' than their current regulation.

 

Ahead of the FDA's plans, you may wish to refresh yourself with the current differences in the layout and structure of the two standards:

 

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 Service 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

 

 

Conclusion

March 2, 2022 may therefore herald a new chapter of stronger, deeper, more internationally converged regulatory guidance for medical device quality professionals.

Watch this space - and while you wait, take a look at the key differences between FDA Title 21 and international medical device regulations.

And you can make your voice heard by submitting your comments on the proposed change by May 24.