QMSR(Quality Management System Regulation)

Why is FDA proposing this change?

To adapt new regularity requirements FDA is proposing One year from the publication of the final rule.FDA正在考虑在国际标准的三年过渡期间与ISO 13485：2016中的21 CFR第820部分中包含的医疗设备质量系统进行协调。

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.

这document FDA released is a proposed rule. The steps should be followed before it’s finalized, including:

• 这 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

尽管如此，这是朝着协调的重要一步，而医疗设备专家长期以来一直在等待。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?

Also Read

• Get to know how to get ISO 13485 certification
• Divergence and Significance between ISO 13485 & ISO 9001: 2015
• International Medical Device Standards: A Look at the ISO 13485 and ISO 14971 updates
• Get to know the importance of the difference between FDA 21 CFR part 820 and iso 13485
• Better Insights For ISO 13485 2016 Validation Requirements
• FDA检查与ISO审核：FDA 21 CFR第820部分和ISO 13485
• Quality Management System (QMS) ISO 13485 Consultation

How does the QMSR differ from the QSR?

这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.”

最好的部分是,这些修改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.根据以下规则和信息，在FDA政府网站上注明的数据可能会有所帮助。

这proposed rule also includes several new sections in Part 820:

• Section 820.7 - Incorporation by reference
• 第820.10节 - Requirements for a quality management system 

• 第820.15节 - 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
管理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	这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建议包括此术语的定义，“因为对拟议规则的解释很重要。FDA指出，它在历史上没有使用该术语，但发现“在整个设备制造过程中涵盖许多类型的个人和组织，例如组件制造商，合同制造商和最终用户。   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
设计验证	Retained without change
Remanufacturer	Retained without change
Nonconformity	Retained without change
Verification	Retained without change

Read More –Ultimate Guide on FDA QSR Compliance for medical device manufacturers

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.

拟议的规则详细说明了三个概念：“组织”，“安全与绩效”和“流程验证”。关于拟议规则，很少有重要的事情需要考虑将FDA QSR与ISO 13485：2016：

• 这r will be a one year waiting period after finalizing the rule  
• 这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.