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FDA's proposal of a revised 21 CFR part 820 to align with ISO 13485:2016

Nadira Salah, PhD
On the 23rd of February 2022, the FDA published their proposal for a revised 21 CFR Part 820, Quality System Regulation. This new proposal aims to align and harmonize the current medical device regulations 21CFR820 and ISO 13485:2016.

FDA has always had an interest in seeking ways to harmonize requirements with ISO 13485 for more global QMS including participation in programs such as the ISO 13485 Voluntary Audit Report Submission Pilot Program and the Medical Device Single Audit Program (MDSAP). 

The proposed new rule/ regulation titled Quality Management System Regulation (QMSR) includes additional definitions, clarifying concepts, and additional requirement to align with existing requirements in the FDA to ensure that the proposed QMSR does not create inconsistencies with other FDA requirements.  

In the proposal, the FDA provides a transparent overview of all proposed changes including the reason for the change, their expectations, and what they have based their decisions on.

Manufacturers of medical devices distributed into the US are advised to read this proposed new rule and if applicable, provide their comments on the proposed QMSR. The deadline for comments on the proposed QMSR is 24th of May 2022.

Proposed changes to requirements for a QMS

1. Definitions

Definitions and terms of both 21 CFR part 820 and ISO 13485:2016 have been revised and the proposed QMSR includes most definitions from ISO 13485:2016 while some definitions have changed or have been added. These include but are not limited to “component”, “finished device”, “design validation”, and “remanufacturer”.

To avoid inconsistencies with the FDA requirements, the QMSR will continue using the definition for “device”, “labelling”, “Manufacturer” and “Product” of the current 21 CFR Part 820 instead of ISO 13485:2016 definitions for “Medical device”, “Labelling”, “Manufacturer”, and “Product”.

Various terms definition will also be either further clarified and expanded including the terms “Act”, “Rework”, “Process validation”, and “Management with executive responsibility”.

2. Incorporation by Reference - Risk based approach

The proposed QMSR will incorporate ISO 13485:2016 risk management principles instead of only addressing risk management activities in the risk analysis requirement within design validation in the current 21 CFR part 820.  This update builds closer linkages to the risk management principles in ISO 14971.

3. Requirements for a QMS

Requirement of a QMS to include a documented QMS that complies to ISO 13485 as modified by the proposed part 820.

Design and development controls to be limited to class II, class III and certain class I devices listed in § 820.30(a).

4. Clarification of concepts

Clarification of concepts including  “Organization”, “Safety and Performance”, and Validation of processes”.

5. Control of records 

The proposed QMSR include additional requirements for control of records than those in ISO 13485:2016. These additional requirements include:

  • Signature and date requirements for each individual that has approved or re-approved records mentioned in ISO 13485:2016 clause 4.2.5.
  • The information required under 21 CFR Part 803, Medical Device Reporting, is captured in complaint files and
  • Records for service activities are kept.
6. Device labelling and packaging controls

The proposed QMSR will keep the requirement for control of labelling and packaging under 21 CFR part 820 as additional requirements to ISO 13485:2016, clause 7.5.1. This is to ensure that manufacturers have:

  • examined labelling and packaging for accuracy prior to release or storage;
  • documented the release of the labelling for use, and
  • inspected the labelling and documented the results of the labelling inspection

Impact on Inspection Process and Procedures

The proposed rule does not impact FDA’s authority to conduct inspections. The intention of the proposed rule is to replace its current Quality System Inspection Technique (QSIT)  approach (which is performing subsystem inspections based on a “top-down” approach) with a new approach and methodology consistent with the amended part 820.  Per the proposed rule, The FDA inspections will not result in the issuance of certificates of conformance to ISO 13485, nor is FDA developing a certification program for ISO 13485.  

What does this mean to manufacturers that have always followed the QSIT model for Inspections? 

This may potentially impact how inspection readiness approach is performed within the organization.  This may include updating information technology systems, training of personnel on ISO 13485 requirements as well the audit model, interpretation of requirements, best practices, revising relevant internal inspection procedures. etc.  For organizations are accustomed to ISO 13485 audits, the impact may be very low.

If you are a manufacturer distributing medical devices to the US and if you need support to assess the impact of FDA’s proposed QMSR on your current QSR or need support with your QMS, please get in touch with us at info@qservegroup.com. We will be more than happy to support you.

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