This Blog speaks about harmonization of FDA QSR and ISO 13485. Those who are new to the industry probably have so many questions like How do we start? Which Regulations need to follow? what is QSMR?
ISO13485 is an international quality management system regulation , whereas US follows their own set of regulation US FDA QSR (21CFRPART820). This means Companies who wish to sell their product in Europe, Australia and other markets needs to follow ISO 13485 standard, whereas Brazil and Japan have their own requirements. The companies who wish to sell their product in US market needs to follow FDA guidelines.
QMSR-(Quality Management system regulation Explained)
QMSR Explained: What FDA QSR and ISO 13485 Harmonization means for Medical Device Companies
After the Four years, the US Food and Drug Administration (FDA) signalled its intent to align its Quality System Regulation (QSR) with the international standard ISO 13485:2016.
As per the FDA’s rule proposed on February 23,2022 for the new QMSR, The proposed QMSR will be the outcome of integrating the FDA\’s Quality System Regulation (QSR) regulations for current Good Manufacturing Practices (cGMP) with ISO 13485:2016, the international consensus standard for medical device quality management systems. According to FDA’s analysis, the regulation as written would result in a cost savings of $439-533 million over 10 years for medical device establishments that comply with both standards.
Why is FDA proposing this change?
To adapt new regularity requirements FDA is proposing One year from the publication of the final rule. FDA is considering to harmonize its regulatory requirements for medical device quality systems contained in 21 CFR part 820 with ISO 13485:2016, amid the international standard’s three-year transition period.
Since spring 2018, FDA has included the QSR update as one of its anticipated regulatory frameworks in each of its biannual unified agendas. The timing for the massive undertaking has moved with each passing year, most recently in the 2021 unified agenda, when the proposed regulation was set to be released in December 2021.
The document FDA released is a proposed rule. The steps should be followed before it’s finalized, including:
- The public advisory committee meeting of the Device Good Manufacturing Practice Advisory Committee on March 2, 2022.
- A 90-day public comment period and subsequent revisions by FDA
- A one-year period between finalization of the rule and its implementation
Still, this is a significant step toward harmonisation, and one that medical device specialists have long awaited. So, let\’s get right to the point: why is the FDA harmonising the rules, what are the new modifications, and how will this affect medical device manufacturers?
How does the QMSR differ from the QSR?
The FDA proposes incorporating ISO 13485 \”by reference,\” which means the new QMSR will address specific standards by noting their location in ISO 13485:2016. Of course, this will result in significant changes to 21 CFR Part 820 as we know it. FDA explains that “proposing additional definitions, clarifying concepts, and additional requirements, all of which would require compliance within a manufacturer’s QMS in addition to ISO 13485.”
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The best part is that many of these modifications are purely semantic and do not affect medical device businesses\’ basic QMS standards. For example, the word \”device master record\” isn\’t used in ISO 13485, and the concept behind it is properly addressed in ISO 13485\’s requirement for a medical device file, according to the present proposal. The data which is stated on FDA’s Government site on the basis of that below rules and information can be helpful.
The proposed rule also includes several new sections in Part 820:
- Section 820.7 - Incorporation by reference
- Section 820.10 - Requirements for a quality management system
- Section 820.15 - Clarification of concepts
- Section 820.35 - Control of records
- Section 820.45 - Device labelling and packaging controls
| Terms that do not appear in ISO 13485 that will be retained | |
| Act | Will explain more precisely reflect the term |
| Management with executive responsibility | This will explain that Senior employees of the manufacturer are responsible for making chances to the quality policy and ensuring the manufacturer follows the policy. |
| Rework | The definition is retained with the removal of the term “device master record (DMR)” as the concept “is adequately covered under the requirements for a medical device file under Clause 4.2.3 of ISO 13485. |
| Process validation | FDA is retaining the definition while clarifying that the term is synonymous with “validation of processes” as used in ISO 13485. |
| Customer | FDA is proposing to include the definition of this term, “as it is important to the interpretation of the proposed rule. FDA notes that it has not historically used the term but finds it useful to “encompass many types of individuals and organizations throughout the device manufacturing process, such as component manufacturers, contract manufacturers, and end users. FDA further explained that it expects manufacturers to comply with the customer property provisions in Clause 7.5.10 of ISO 13485 “to the extent necessary to assure the safety and effectiveness of the devices being manufactured.” However, FDA notes that it does not intend to enforce any customer property provisions that go beyond the safety and effectiveness of the devices being manufactured. |
| Component | Retained without change |
| Finished device | Retained without change |
| Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device | Retained without change |
| Design validation | Retained without change |
| Remanufacturer | Retained without change |
| Nonconformity | Retained without change |
| Verification | Retained without change |
What does the FDA QSR transition to ISO 13485 mean for Medical Device Manufacturer?
While this may appear to be a significant change for medical device manufacturers, it\’s worth noting that the FDA already considers ISO 13485 to be quite similar to the present QSR. It\’s a good thing to keep a watch on this proposed rule and any amendments that emerge following the public comment period, but it won\’t require a total redesign of your quality management system. This harmonization is much more about making everyone\’s life simpler.
The proposed rule in detail explains about three concepts: “organization,” “safety and performance” and “validation of processes.” Few important things needs to consider regarding the proposed rule to harmonize the FDA QSR with ISO 13485:2016:
- Ther will be a one year waiting period after finalizing the rule
- The proposed rule would also result in the replacement of the current Quality System Inspection Technique (QSIT) with a new approach that is consistent with the new QMSR requirements.
- FDA is making process smoother to harmonise the QSR with ISO13485:2016 ,which is the latest version of the ISO standard. Any future revision to ISO 13485 would first need to be evaluated by FDA before being incorporated into the QMSR.
- QMSR will be harmonized with ISO 13485, does not mean that one will be issued an ISO 13485 certification of conformance after an inspection. And if you already are ISO 13485 certified, then also you will not get any exemption from FDA Inspection process.
This is a proposed rule This is subject to change. To get more detail you can read up on how FDA views the relationship between the QSR And ISO 13485 .You can also check news About FDA updated rules on our website.
