QMSR(Quality Management System Regulation)

Why is FDA proposing this change?

为了适应新的规律要求，FDA提议从最终规则发布一年。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.

自2018年春季以来，FDA将QSR更新纳入了其每双统一议程中的预期监管框架之一。大规模承诺的时机已经与每年的时间有关，最近一次是在2021年的统一议程中，当时拟议的法规定于2021年12月发布。

文件FDA发布的是 proposed rule. The steps should be followed before it’s finalized, including:

• The 公共咨询委员会会议 of the Device Good Manufacturing Practice Advisory Committee on March 2, 2022.
• A 90-day public comment period and subsequent revisions by FDA
• 该规则的最终确定及其实施之间的一年

Still, this is a significant step toward harmonisation, and one that medical device specialists have long awaited.因此，让我们正确地说明：为什么FDA协调规则，新的修改是什么，这将如何影响医疗设备制造商？

也可以阅读

• Get to know how to get ISO 13485 certification
• Divergence and Significance between ISO 13485 & ISO 9001: 2015
• 国际医疗设备标准：查看ISO 13485和ISO 14971更新
• Get to know the importance of the difference between FDA 21 CFR part 820 and iso 13485
• ISO 13485 2016验证要求的更好见解
• FDA Inspections vs ISO Audits : FDA 21 CFR Part 820 and ISO 13485
• 质量管理系统（QMS）ISO 13485咨询

How does the QMSR differ from the QSR?

FDA提议将ISO 13485“通过参考”合并，这意味着新QMSR将通过在ISO 13485：2016中指出其位置来解决特定标准。当然，这将导致对21 CFR第820部分的重大变化。FDA解释说：“提出其他定义，澄清概念和其他要求，除了ISO 13485。

• QMS certification serviceincluding QMS certification training, layout designs, manufacturing and post market support as we have regulatory expertise in auditing, executing and maintaining all features.

• Our team involves in former U.S. FDA, EU notified body, QMS certification body and Medical Devices Agency professionals with the well built technical expertise

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.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:

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

• Section 820.15 - Clarification of concepts
• 第820.35节 - Control of records
• 第820.45节 - Device labelling and packaging controls

Terms that do not appear in ISO 13485 that will be retained
Act	将更准确地解释该术语
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	该定义是通过删除“设备主记录（DMR）”一词来保留的，因为该概念“根据ISO 13485第4.2.3条的医疗设备文件的要求充分涵盖了该概念。
流程验证	FDA在澄清ISO 13485中使用的“验证过程验证”的同义词时保留了该定义。
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进一步解释说，它希望制造商遵守ISO 13485第7.5.10条中的客户财产规定，“在确保所制造设备的安全性和有效性的必要范围内。”但是，FDA指出，它不打算执行任何超出正在制造设备的安全性和有效性的客户物业规定。
零件	Retained without change
完成的设备	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
再制造商	Retained without change
不合格	Retained without change
确认	Retained without change

阅读更多 -终极指南FDA近年合规医疗device manufacturers

FDA QSR过渡到ISO 13485对于医疗设备制造商意味着什么？

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正在使过程更加顺畅，以将QSR与ISO13485：2016进行协调，这是ISO标准的最新版本。将来对ISO 13485的任何未来修订都将首先由FDA评估，然后再将其纳入QMSR。
• QMSR将与ISO 13485进行协调，并不意味着在检查后将颁发ISO 13485一致性认证。而且，如果您已经经过13485认证，那么您也不会从FDA检查过程中获得任何豁免。

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.