Regulatory Open Forum

Hi all,

I am trying to locate any regulatory requirements on the mole % of residual monomer for PLA polylactic acid biodegradable polymer for implantable medical devices. Our company initially has a technical spec of less than <2% mole back in 2008 but some how it was changed to <1.2% mole. I am trying to trace back the regulatory rationale for updating the spec change from 2% mole to 1.2% mole by referencing to some ISO, ASTM standards or some US FDA requirements etc but can't find any so far. Am wondering whether anyone here could help to point to the relevant regulatory guidance or standards. Thank you in advance.

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Hi We-Beng,

To my knowledge, I don't think you will find any specific requirement for the residual monomer. If someone knows something more, any further insight is more than welcomed.

You have to base your specs on the toxicological risk assessment.
Have you searched any specs from similar devices?

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece
------------------------------

Original Message:
Sent: 02-Sep-2020 04:15
From: Wei-Beng Ng
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hi all,

I am trying to locate any regulatory requirements on the mole % of residual monomer for PLA polylactic acid biodegradable polymer for implantable medical devices. Our company initially has a technical spec of less than <2% mole back in 2008 but some how it was changed to <1.2% mole. I am trying to trace back the regulatory rationale for updating the spec change from 2% mole to 1.2% mole by referencing to some ISO, ASTM standards or some US FDA requirements etc but can't find any so far. Am wondering whether anyone here could help to point to the relevant regulatory guidance or standards. Thank you in advance.

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Hi Spyros Drivelos,

Thank you for your comments and feedback. So far I do not have any luck in finding related spec in other similar devices. I will keep searching for a while.... :-)

Best regards

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Original Message:
Sent: 03-Sep-2020 02:35
From: Spyros Drivelos
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hi We-Beng,

To my knowledge, I don't think you will find any specific requirement for the residual monomer. If someone knows something more, any further insight is more than welcomed.

You have to base your specs on the toxicological risk assessment.
Have you searched any specs from similar devices?

------------------------------
Spyros Drivelos
Medical Devices Expert, RAC
Agia Paraskevi, Athens
Greece

Original Message:
Sent: 02-Sep-2020 04:15
From: Wei-Beng Ng
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hi all,

I am trying to locate any regulatory requirements on the mole % of residual monomer for PLA polylactic acid biodegradable polymer for implantable medical devices. Our company initially has a technical spec of less than <2% mole back in 2008 but some how it was changed to <1.2% mole. I am trying to trace back the regulatory rationale for updating the spec change from 2% mole to 1.2% mole by referencing to some ISO, ASTM standards or some US FDA requirements etc but can't find any so far. Am wondering whether anyone here could help to point to the relevant regulatory guidance or standards. Thank you in advance.

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Hey Wei-Beng,

I don't know of anything off-hand that this would specifically correlate to.  Have you discussed with your polymer engineer or supplier?  Perhaps it's set at that level for manufacurability of the final product and not related to a regulation at all.

Good Luck!

------------------------------
Sarah Ware
Minneapolis MN
United States
------------------------------

Original Message:
Sent: 02-Sep-2020 04:15
From: Wei-Beng Ng
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hi all,

I am trying to locate any regulatory requirements on the mole % of residual monomer for PLA polylactic acid biodegradable polymer for implantable medical devices. Our company initially has a technical spec of less than <2% mole back in 2008 but some how it was changed to <1.2% mole. I am trying to trace back the regulatory rationale for updating the spec change from 2% mole to 1.2% mole by referencing to some ISO, ASTM standards or some US FDA requirements etc but can't find any so far. Am wondering whether anyone here could help to point to the relevant regulatory guidance or standards. Thank you in advance.

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Hi Sarah,

Thanks for the suggestion. As the spec change was dated back to 2008 without proper documentation it's kinda hard to trace now. Our engineer is also not able to provide any clue in terms of regulatory requirement. Anyway I will try my best. Thank you.

Best regards

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Original Message:
Sent: 03-Sep-2020 10:47
From: Sarah Ware
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hey Wei-Beng,

I don't know of anything off-hand that this would specifically correlate to.  Have you discussed with your polymer engineer or supplier?  Perhaps it's set at that level for manufacurability of the final product and not related to a regulation at all.

Good Luck!

------------------------------
Sarah Ware
Minneapolis MN
United States

Original Message:
Sent: 02-Sep-2020 04:15
From: Wei-Beng Ng
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hi all,

I am trying to locate any regulatory requirements on the mole % of residual monomer for PLA polylactic acid biodegradable polymer for implantable medical devices. Our company initially has a technical spec of less than <2% mole back in 2008 but some how it was changed to <1.2% mole. I am trying to trace back the regulatory rationale for updating the spec change from 2% mole to 1.2% mole by referencing to some ISO, ASTM standards or some US FDA requirements etc but can't find any so far. Am wondering whether anyone here could help to point to the relevant regulatory guidance or standards. Thank you in advance.

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

I kind of doubt you will find anything that specific, but if you do, it would almost certainly be in the guidance documents around sutures, which are the most (only) well developed thinking on resorbables.

My suspicion though, is the "spec" got established in your original design, and whoever evaluated the change thought "it is lower than the original 510(k) so it must be consistent with it."

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN
------------------------------

Original Message:
Sent: 03-Sep-2020 20:37
From: Wei-Beng Ng
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hi Sarah,

Thanks for the suggestion. As the spec change was dated back to 2008 without proper documentation it's kinda hard to trace now. Our engineer is also not able to provide any clue in terms of regulatory requirement. Anyway I will try my best. Thank you.

Best regards

------------------------------
Wei-Beng Ng
Singapore
Singapore

Original Message:
Sent: 03-Sep-2020 10:47
From: Sarah Ware
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hey Wei-Beng,

I don't know of anything off-hand that this would specifically correlate to.  Have you discussed with your polymer engineer or supplier?  Perhaps it's set at that level for manufacurability of the final product and not related to a regulation at all.

Good Luck!

------------------------------
Sarah Ware
Minneapolis MN
United States

Original Message:
Sent: 02-Sep-2020 04:15
From: Wei-Beng Ng
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hi all,

I am trying to locate any regulatory requirements on the mole % of residual monomer for PLA polylactic acid biodegradable polymer for implantable medical devices. Our company initially has a technical spec of less than <2% mole back in 2008 but some how it was changed to <1.2% mole. I am trying to trace back the regulatory rationale for updating the spec change from 2% mole to 1.2% mole by referencing to some ISO, ASTM standards or some US FDA requirements etc but can't find any so far. Am wondering whether anyone here could help to point to the relevant regulatory guidance or standards. Thank you in advance.

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

HI Ginger Glaser,

Thanks for your thoughts :-) Let me dig into the sutures space and see whether I can find anything. Thanks

Best regards

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------

Original Message:
Sent: 09-Sep-2020 10:03
From: Ginger Glaser
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

I kind of doubt you will find anything that specific, but if you do, it would almost certainly be in the guidance documents around sutures, which are the most (only) well developed thinking on resorbables.

My suspicion though, is the "spec" got established in your original design, and whoever evaluated the change thought "it is lower than the original 510(k) so it must be consistent with it."

g-

------------------------------
Ginger Glaser RAC
Chief Technology Officer
MN

Original Message:
Sent: 03-Sep-2020 20:37
From: Wei-Beng Ng
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hi Sarah,

Thanks for the suggestion. As the spec change was dated back to 2008 without proper documentation it's kinda hard to trace now. Our engineer is also not able to provide any clue in terms of regulatory requirement. Anyway I will try my best. Thank you.

Best regards

------------------------------
Wei-Beng Ng
Singapore
Singapore

Original Message:
Sent: 03-Sep-2020 10:47
From: Sarah Ware
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hey Wei-Beng,

I don't know of anything off-hand that this would specifically correlate to.  Have you discussed with your polymer engineer or supplier?  Perhaps it's set at that level for manufacurability of the final product and not related to a regulation at all.

Good Luck!

------------------------------
Sarah Ware
Minneapolis MN
United States

Original Message:
Sent: 02-Sep-2020 04:15
From: Wei-Beng Ng
Subject: Regulatory requirement on residual monomer % for PLA PolyLactic Acid Biodegradable polymer in implantable medical devices

Hi all,

I am trying to locate any regulatory requirements on the mole % of residual monomer for PLA polylactic acid biodegradable polymer for implantable medical devices. Our company initially has a technical spec of less than <2% mole back in 2008 but some how it was changed to <1.2% mole. I am trying to trace back the regulatory rationale for updating the spec change from 2% mole to 1.2% mole by referencing to some ISO, ASTM standards or some US FDA requirements etc but can't find any so far. Am wondering whether anyone here could help to point to the relevant regulatory guidance or standards. Thank you in advance.

------------------------------
Wei-Beng Ng
Singapore
Singapore
------------------------------