Regulatory Open Forum

Hello All

I'm trying to get some clarity regarding health authority expectations for testing being done under GLPs.  FDA has not required us to conduct testing in accordance with GLPs for our 510(k)s, but based on the proposed rule from 2016 (link below), it seems that they are likely to require it in the future.  I am also being asked whether OUS health authorities require that testing be done under GLPs.

https://www.fda.gov/media/99828/download

Who out there has a good grasp on current GLP testing expectations both by FDA and by other OUS health authorities?  I would certainly appreciate any clarity that you can provide!

Thanks tons and Best Regards,  Lauren

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States
------------------------------

Hi Lauren,

I think we may need further more information to clearly define if GLP regulations would apply or not. (e.g. Biocompatability testing or validation / sterilization etc.) We need to understand the type of testing that you are doing under 510 (k). I have seen medical device implants  (PMA) being tested as part of preclinical testing which would require GLP principles to be followed.

Also, OUS authorities might apply OECD GLP principles if you are referring to a country who falls under OECD.

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
------------------------------

Original Message:
Sent: 02-May-2019 12:12
From: Lauren Kamer
Subject: GLP Testing Expectations

Hello All

I'm trying to get some clarity regarding health authority expectations for testing being done under GLPs.  FDA has not required us to conduct testing in accordance with GLPs for our 510(k)s, but based on the proposed rule from 2016 (link below), it seems that they are likely to require it in the future.  I am also being asked whether OUS health authorities require that testing be done under GLPs.

https://www.fda.gov/media/99828/download

Who out there has a good grasp on current GLP testing expectations both by FDA and by other OUS health authorities?  I would certainly appreciate any clarity that you can provide!

Thanks tons and Best Regards,  Lauren

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States
------------------------------

Hello Loganathan

Thank you for your reply and I apologize for being vague.  In this case I am referring to steam sterilization validation.

Best Regards,  Lauren

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States
------------------------------

Original Message:
Sent: 06-May-2019 14:39
From: Loganathan Kumarasamy, MS RAC
Subject: GLP Testing Expectations

Hi Lauren,

I think we may need further more information to clearly define if GLP regulations would apply or not. (e.g. Biocompatability testing or validation / sterilization etc.) We need to understand the type of testing that you are doing under 510 (k). I have seen medical device implants  (PMA) being tested as part of preclinical testing which would require GLP principles to be followed.

Also, OUS authorities might apply OECD GLP principles if you are referring to a country who falls under OECD.

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States

Original Message:
Sent: 02-May-2019 12:12
From: Lauren Kamer
Subject: GLP Testing Expectations

Hello All

I'm trying to get some clarity regarding health authority expectations for testing being done under GLPs.  FDA has not required us to conduct testing in accordance with GLPs for our 510(k)s, but based on the proposed rule from 2016 (link below), it seems that they are likely to require it in the future.  I am also being asked whether OUS health authorities require that testing be done under GLPs.

https://www.fda.gov/media/99828/download

Who out there has a good grasp on current GLP testing expectations both by FDA and by other OUS health authorities?  I would certainly appreciate any clarity that you can provide!

Thanks tons and Best Regards,  Lauren

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States
------------------------------

Hi Lauren,

In my opinion, I do not think a sterilization validation study would need to comply with GLP principles are you are not doing an intrinsic safety assessment. However, it would be good to have a separate quality unit group who could oversee the study to make sure there is no bias and following the general data principles would be sufficient .

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States
------------------------------

Original Message:
Sent: 06-May-2019 14:57
From: Lauren Kamer
Subject: GLP Testing Expectations

Hello Loganathan

Thank you for your reply and I apologize for being vague.  In this case I am referring to steam sterilization validation.

Best Regards,  Lauren

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States

Original Message:
Sent: 06-May-2019 14:39
From: Loganathan Kumarasamy, MS RAC
Subject: GLP Testing Expectations

Hi Lauren,

I think we may need further more information to clearly define if GLP regulations would apply or not. (e.g. Biocompatability testing or validation / sterilization etc.) We need to understand the type of testing that you are doing under 510 (k). I have seen medical device implants  (PMA) being tested as part of preclinical testing which would require GLP principles to be followed.

Also, OUS authorities might apply OECD GLP principles if you are referring to a country who falls under OECD.

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States

Original Message:
Sent: 02-May-2019 12:12
From: Lauren Kamer
Subject: GLP Testing Expectations

Hello All

I'm trying to get some clarity regarding health authority expectations for testing being done under GLPs.  FDA has not required us to conduct testing in accordance with GLPs for our 510(k)s, but based on the proposed rule from 2016 (link below), it seems that they are likely to require it in the future.  I am also being asked whether OUS health authorities require that testing be done under GLPs.

https://www.fda.gov/media/99828/download

Who out there has a good grasp on current GLP testing expectations both by FDA and by other OUS health authorities?  I would certainly appreciate any clarity that you can provide!

Thanks tons and Best Regards,  Lauren

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States
------------------------------

Thank you Loganathan for your advice.

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States
------------------------------

Original Message:
Sent: 06-May-2019 15:03
From: Loganathan Kumarasamy, MS RAC
Subject: GLP Testing Expectations

Hi Lauren,

In my opinion, I do not think a sterilization validation study would need to comply with GLP principles are you are not doing an intrinsic safety assessment. However, it would be good to have a separate quality unit group who could oversee the study to make sure there is no bias and following the general data principles would be sufficient .

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States

Original Message:
Sent: 06-May-2019 14:57
From: Lauren Kamer
Subject: GLP Testing Expectations

Hello Loganathan

Thank you for your reply and I apologize for being vague.  In this case I am referring to steam sterilization validation.

Best Regards,  Lauren

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States

Original Message:
Sent: 06-May-2019 14:39
From: Loganathan Kumarasamy, MS RAC
Subject: GLP Testing Expectations

Hi Lauren,

I think we may need further more information to clearly define if GLP regulations would apply or not. (e.g. Biocompatability testing or validation / sterilization etc.) We need to understand the type of testing that you are doing under 510 (k). I have seen medical device implants  (PMA) being tested as part of preclinical testing which would require GLP principles to be followed.

Also, OUS authorities might apply OECD GLP principles if you are referring to a country who falls under OECD.

------------------------------
Loganathan Kumarasamy, MS RAC
Senior Consultant
Waukegan IL
United States

Original Message:
Sent: 02-May-2019 12:12
From: Lauren Kamer
Subject: GLP Testing Expectations

Hello All

I'm trying to get some clarity regarding health authority expectations for testing being done under GLPs.  FDA has not required us to conduct testing in accordance with GLPs for our 510(k)s, but based on the proposed rule from 2016 (link below), it seems that they are likely to require it in the future.  I am also being asked whether OUS health authorities require that testing be done under GLPs.

https://www.fda.gov/media/99828/download

Who out there has a good grasp on current GLP testing expectations both by FDA and by other OUS health authorities?  I would certainly appreciate any clarity that you can provide!

Thanks tons and Best Regards,  Lauren

------------------------------
Lauren Kamer RAC
Director of Regulatory
United States
------------------------------