问MSR(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 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?

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 Inspections vs ISO Audits : FDA 21 CFR Part 820 and ISO 13485
• 问uality Management System (QMS) ISO 13485 Consultation

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.”

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

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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:

• Section 820.7 - Incorporation by reference
• Section 820.10  -需求质量管理系统

• 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	保留无需更改
Finished device	保留无需更改
Human cell, tissue, or cellular or tissue-based product (HCT/P) regulated as a device	保留无需更改
Design validation	保留无需更改
Remanufacturer	保留无需更改
Nonconformity	保留无需更改
Verification	保留无需更改

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.

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.
• 问MSR 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.