Regulatory Open Forum

I went through both CFR versions and looked at the most recent FDA 21 CFR 820, but I didn't notice any changes. I would like to know what specifically changed regarding the content of the regulations.

21 CFR Part 820 is very stable; it seldom changes. The most recent change was in 2013 to implement the UDI rule.<o:p></o:p>

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FDA is planning a major revision which will include a name change from QSR to QMSR. The current plan is to publish the final rule in December 2023.<o:p></o:p>

I went through both CFR versions and looked at the most recent FDA 21 CFR 820, but I didn't notice any changes. I would like to know what specifically changed regarding the content of the regulations.

Attended MedCon last week where FDA presented on the upcoming QMSR.  There was an article published on RAPS RF Today yesterday about the presentation.

As Dan stated the current plan indicates December 2023 for the update,  BUT there will be an update to the plan in June, so watch for that.  One of the things FDA has to accomplish is a re-write of the QSIT document for investigators to follow during an investigation, that may be a critical path item which could delay it.  FDA is already training the workforce on both ISO 13485:2016 and ISO 14971:2019 to prepare the workforce in both the field investigators and the premarket review teams.  ISO 14971 will be an important consideration for the agency, as risk is mentioned in a number of places in ISO 13485 unlike the one reference in 21 CFR 820.  It will also be more than just design-development, and will be part of post-market as well as purchasing and other parts of the new regulation.  Note that ISO 13485 is much more expansive in the postmarket than just CAPA and Complaints.  An Active process is required over the passive process of waiting for complaints to come in you must be searching for information in places such as registries, internet groups, snd your own studies of performance of the device in the field.  GHTF SG3/N18 the guidance on CAPA has some great information on the postmarket processes, and may be found at International Medical Device Regulators Forum (IMDRF)

Also GHTF SG3/N17 on Supplier Quality is also a great reference on the Purchasing requirements in ISO 13485:2016.  Both the N17 and N18 BSc, ASQ Fellowdocuments were used as input on development of 13485.  As a final note, in the preparation for the new QMSR CDRH looked at the differences between 13485 and 21 CFR 820 (1996) and found they were 95% the same, but the 5% will require some work to implement.  

21 CFR Part 820 is very stable; it seldom changes. The most recent change was in 2013 to implement the UDI rule.<o:p></o:p>

<o:p> </o:p>

FDA is planning a major revision which will include a name change from QSR to QMSR. The current plan is to publish the final rule in December 2023.<o:p></o:p>

I went through both CFR versions and looked at the most recent FDA 21 CFR 820, but I didn't notice any changes. I would like to know what specifically changed regarding the content of the regulations.

Thank you for your response. This means that by the end of the 2023, we will need to completely revise all of our references and switch from using the ISO13485 and 21CFR820 as separate sources of information to using the QMSR. kindly correct me if I'm wrong.

Attended MedCon last week where FDA presented on the upcoming QMSR.  There was an article published on RAPS RF Today yesterday about the presentation.

As Dan stated the current plan indicates December 2023 for the update,  BUT there will be an update to the plan in June, so watch for that.  One of the things FDA has to accomplish is a re-write of the QSIT document for investigators to follow during an investigation, that may be a critical path item which could delay it.  FDA is already training the workforce on both ISO 13485:2016 and ISO 14971:2019 to prepare the workforce in both the field investigators and the premarket review teams.  ISO 14971 will be an important consideration for the agency, as risk is mentioned in a number of places in ISO 13485 unlike the one reference in 21 CFR 820.  It will also be more than just design-development, and will be part of post-market as well as purchasing and other parts of the new regulation.  Note that ISO 13485 is much more expansive in the postmarket than just CAPA and Complaints.  An Active process is required over the passive process of waiting for complaints to come in you must be searching for information in places such as registries, internet groups, snd your own studies of performance of the device in the field.  GHTF SG3/N18 the guidance on CAPA has some great information on the postmarket processes, and may be found at International Medical Device Regulators Forum (IMDRF)

Also GHTF SG3/N17 on Supplier Quality is also a great reference on the Purchasing requirements in ISO 13485:2016.  Both the N17 and N18 BSc, ASQ Fellowdocuments were used as input on development of 13485.  As a final note, in the preparation for the new QMSR CDRH looked at the differences between 13485 and 21 CFR 820 (1996) and found they were 95% the same, but the 5% will require some work to implement.  

21 CFR Part 820 is very stable; it seldom changes. The most recent change was in 2013 to implement the UDI rule.<o:p></o:p>

<o:p> </o:p>

FDA is planning a major revision which will include a name change from QSR to QMSR. The current plan is to publish the final rule in December 2023.<o:p></o:p>

I went through both CFR versions and looked at the most recent FDA 21 CFR 820, but I didn't notice any changes. I would like to know what specifically changed regarding the content of the regulations.

Thank you for your response. This means that by the end of the 2023, we will need to completely revise all of our references and switch from using the ISO13485 and 21CFR820 as separate sources of information to using the QMSR. kindly correct me if I'm wrong.

Attended MedCon last week where FDA presented on the upcoming QMSR.  There was an article published on RAPS RF Today yesterday about the presentation.

As Dan stated the current plan indicates December 2023 for the update,  BUT there will be an update to the plan in June, so watch for that.  One of the things FDA has to accomplish is a re-write of the QSIT document for investigators to follow during an investigation, that may be a critical path item which could delay it.  FDA is already training the workforce on both ISO 13485:2016 and ISO 14971:2019 to prepare the workforce in both the field investigators and the premarket review teams.  ISO 14971 will be an important consideration for the agency, as risk is mentioned in a number of places in ISO 13485 unlike the one reference in 21 CFR 820.  It will also be more than just design-development, and will be part of post-market as well as purchasing and other parts of the new regulation.  Note that ISO 13485 is much more expansive in the postmarket than just CAPA and Complaints.  An Active process is required over the passive process of waiting for complaints to come in you must be searching for information in places such as registries, internet groups, snd your own studies of performance of the device in the field.  GHTF SG3/N18 the guidance on CAPA has some great information on the postmarket processes, and may be found at International Medical Device Regulators Forum (IMDRF)

Also GHTF SG3/N17 on Supplier Quality is also a great reference on the Purchasing requirements in ISO 13485:2016.  Both the N17 and N18 BSc, ASQ Fellowdocuments were used as input on development of 13485.  As a final note, in the preparation for the new QMSR CDRH looked at the differences between 13485 and 21 CFR 820 (1996) and found they were 95% the same, but the 5% will require some work to implement.  

21 CFR Part 820 is very stable; it seldom changes. The most recent change was in 2013 to implement the UDI rule.<o:p></o:p>

<o:p> </o:p>

FDA is planning a major revision which will include a name change from QSR to QMSR. The current plan is to publish the final rule in December 2023.<o:p></o:p>

I went through both CFR versions and looked at the most recent FDA 21 CFR 820, but I didn't notice any changes. I would like to know what specifically changed regarding the content of the regulations.

I went through both CFR versions and looked at the most recent FDA 21 CFR 820, but I didn't notice any changes. I would like to know what specifically changed regarding the content of the regulations.

Yes, you are correct. There have been no changes in 2021 through current. The last redline was per 85 FR 14422 on Apr. 2, 2020

I went through both CFR versions and looked at the most recent FDA 21 CFR 820, but I didn't notice any changes. I would like to know what specifically changed regarding the content of the regulations.

Yes, you are correct. There have been no changes in 2021 through current. The last redline was per 85 FR 14422 on Apr. 2, 2020

I went through both CFR versions and looked at the most recent FDA 21 CFR 820, but I didn't notice any changes. I would like to know what specifically changed regarding the content of the regulations.

thank you @Ajit Basrur , that was very helpful to go through the changes .

Yes, you are correct. There have been no changes in 2021 through current. The last redline was per 85 FR 14422 on Apr. 2, 2020

I went through both CFR versions and looked at the most recent FDA 21 CFR 820, but I didn't notice any changes. I would like to know what specifically changed regarding the content of the regulations.