Regulatory Open Forum

Dear all

I fail to understand when FDA pre-approval inspections can occur. The sources I found say that they occur after the company submits an application to market a new product. In some cases they specifically refer to PMA (Premarket Approval Application). In other cases they imply that it is needed for any new product not on the market yet.

In my case I would like to place a product on the US market, the type of which has an existing regulation number and is exempt from the 510(k). Thus, there are similar products by other brands on the US market already. Am I to expect an FDA pre-approval inspection once I submit the application to place our product on the market?

Thank you so much for your clarification.

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Richard,

In the US, the term "approval" carries significant weight for medical devices. Whereas a PMA results in "approval", a 510(k) results in "clearance" and a 510(k) exempt product is "listed". Pre-market inspection is associated with the PMA pathway due to the high risk of these products. If your device is 510(k) exempt then you will be able to list it without waiting for 510(k) clearance or pre-market approval and no pre-market inspection will be required.

If your device is only class I (which is likely if it is 510(k) exempt), then your main risk of FDA audits will be "for cause" audits which result from issues brought to the attention of the FDA (e.g. incidents, complaints, etc.).


------------------------------
Ian Boland
Regulatory Affairs Specialist
NJ
United States
------------------------------

Original Message:
Sent: 25-Jan-2023 04:52
From: Richard Jansky
Subject: FDA pre-approval inspections

Dear all

I fail to understand when FDA pre-approval inspections can occur. The sources I found say that they occur after the company submits an application to market a new product. In some cases they specifically refer to PMA (Premarket Approval Application). In other cases they imply that it is needed for any new product not on the market yet.

In my case I would like to place a product on the US market, the type of which has an existing regulation number and is exempt from the 510(k). Thus, there are similar products by other brands on the US market already. Am I to expect an FDA pre-approval inspection once I submit the application to place our product on the market?

Thank you so much for your clarification.

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Richard,

It would be helpful for us to see your sources, as their contexts could shed more light on potential ambiguities.  In the meantime, I'll give additional insights building on Ian's great comments regarding Pre-Approval Inspections (PAI) and their focus on PMA devices rather than 510(k) devices.

Namely, two key U.S. premarket pathways for medical devices are FD&C Act section 510(k) (premarket notification and "clearance") and section 515 (premarket "approval").  Their unique intrinsic statutory purposes are what drive FDA's pursuit (or lack thereof) of premarket / preapproval inspection.

Specifically, the statutory basis of section 510(k) is generally aimed at determining "substantial equivalence" of the subject device, which means, with respect to a legally marketed predicate device, that the subject device has the same intended use as the predicate device and that it either (i) has the same technological characteristics as the predicate device, or (ii)(I) has different technological characteristics that don't raise different questions of safety and effectiveness than the predicate device.  In general, premarket FDA inspection is not generally deemed necessary for meeting the statutory substantial equivalence ("clearance") threshold.  Indeed, only a few aspects of the subject device's GMPs, if any at all, are addressed in a 510(k) notification.  This pathway is most typically used for Class II devices, but also for Class I devices that are not 510(k)-exempt, and some Class III devices that don't require PMA.

In contrast, the basis of section 515 is "approval" of the subject device.  It is reserved for Class III devices.  One of multiple statutory thresholds for premarket "approval" (PMA) is conformity with GMP [see sections 515(d)(2)(C) and 520(f) of the FD&C Act].  Accordingly, FDA performs PAIs for PMA devices before granting premarket approval of the subject device.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.
------------------------------

Original Message:
Sent: 25-Jan-2023 04:52
From: Richard Jansky
Subject: FDA pre-approval inspections

Dear all

I fail to understand when FDA pre-approval inspections can occur. The sources I found say that they occur after the company submits an application to market a new product. In some cases they specifically refer to PMA (Premarket Approval Application). In other cases they imply that it is needed for any new product not on the market yet.

In my case I would like to place a product on the US market, the type of which has an existing regulation number and is exempt from the 510(k). Thus, there are similar products by other brands on the US market already. Am I to expect an FDA pre-approval inspection once I submit the application to place our product on the market?

Thank you so much for your clarification.

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hello Richard,

A Pre-Approval Inspection or PAI is only required with a Pre-Market Approval (PMA) submission through the US FDA https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-contents (and also reference the various guidance documents).  Well I should say generally only required.  If a De Novo submission is made and happens to fall into the Class III/PMA area - well still being a PMA - then would require a PAI.  For other Class II and I devices, including 510(k) Exempt) products, an inspection is performed routinely according to the compliance requirements and the regulations.  It is by law they have to inspect every two years, but this does not happen due to the sheer numbers of manufacturers (one of the changes supposedly being introduced using risk-based approach on inspections when they overhaul the Quality System Regulation).  If your device is 510(k) Exempt, then when your establishment is registered this allows the US FDA to inspect your facility at any time; but for 510(k) Exempt devices there is no PAI done.  It does not mean the FDA may not show up 1 month after your establishment is registered or they could show up 5 years later ... but they can perform an inspection at any time.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
------------------------------

Original Message:
Sent: 25-Jan-2023 12:49
From: Kevin Randall
Subject: FDA pre-approval inspections

Hi Richard,

It would be helpful for us to see your sources, as their contexts could shed more light on potential ambiguities.  In the meantime, I'll give additional insights building on Ian's great comments regarding Pre-Approval Inspections (PAI) and their focus on PMA devices rather than 510(k) devices.

Namely, two key U.S. premarket pathways for medical devices are FD&C Act section 510(k) (premarket notification and "clearance") and section 515 (premarket "approval").  Their unique intrinsic statutory purposes are what drive FDA's pursuit (or lack thereof) of premarket / preapproval inspection.

Specifically, the statutory basis of section 510(k) is generally aimed at determining "substantial equivalence" of the subject device, which means, with respect to a legally marketed predicate device, that the subject device has the same intended use as the predicate device and that it either (i) has the same technological characteristics as the predicate device, or (ii)(I) has different technological characteristics that don't raise different questions of safety and effectiveness than the predicate device.  In general, premarket FDA inspection is not generally deemed necessary for meeting the statutory substantial equivalence ("clearance") threshold.  Indeed, only a few aspects of the subject device's GMPs, if any at all, are addressed in a 510(k) notification.  This pathway is most typically used for Class II devices, but also for Class I devices that are not 510(k)-exempt, and some Class III devices that don't require PMA.

In contrast, the basis of section 515 is "approval" of the subject device.  It is reserved for Class III devices.  One of multiple statutory thresholds for premarket "approval" (PMA) is conformity with GMP [see sections 515(d)(2)(C) and 520(f) of the FD&C Act].  Accordingly, FDA performs PAIs for PMA devices before granting premarket approval of the subject device.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 25-Jan-2023 04:52
From: Richard Jansky
Subject: FDA pre-approval inspections

Dear all

I fail to understand when FDA pre-approval inspections can occur. The sources I found say that they occur after the company submits an application to market a new product. In some cases they specifically refer to PMA (Premarket Approval Application). In other cases they imply that it is needed for any new product not on the market yet.

In my case I would like to place a product on the US market, the type of which has an existing regulation number and is exempt from the 510(k). Thus, there are similar products by other brands on the US market already. Am I to expect an FDA pre-approval inspection once I submit the application to place our product on the market?

Thank you so much for your clarification.

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Thank you Ian, Kevin, and Richard for your insights! That is very helpful.

One clarification to Ian: Our device is 510(k) exempt, but class II. Thus, in addition to the "for cause" inspections, we can also expect routine and potentially follow-up inspections, correct?

To Kevin: In retrospect I believe the sources are correct. It is my misinterpretation of the term "new product" as they must mean "an unapproved product". One example is "Pre-approval inspections are conducted on all new products. Once an application to introduce a new product to market is submitted, the FDA will make an inspection."

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Original Message:
Sent: 26-Jan-2023 04:09
From: Richard Vincins
Subject: FDA pre-approval inspections

Hello Richard,

A Pre-Approval Inspection or PAI is only required with a Pre-Market Approval (PMA) submission through the US FDA https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-contents (and also reference the various guidance documents).  Well I should say generally only required.  If a De Novo submission is made and happens to fall into the Class III/PMA area - well still being a PMA - then would require a PAI.  For other Class II and I devices, including 510(k) Exempt) products, an inspection is performed routinely according to the compliance requirements and the regulations.  It is by law they have to inspect every two years, but this does not happen due to the sheer numbers of manufacturers (one of the changes supposedly being introduced using risk-based approach on inspections when they overhaul the Quality System Regulation).  If your device is 510(k) Exempt, then when your establishment is registered this allows the US FDA to inspect your facility at any time; but for 510(k) Exempt devices there is no PAI done.  It does not mean the FDA may not show up 1 month after your establishment is registered or they could show up 5 years later ... but they can perform an inspection at any time.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 25-Jan-2023 12:49
From: Kevin Randall
Subject: FDA pre-approval inspections

Hi Richard,

It would be helpful for us to see your sources, as their contexts could shed more light on potential ambiguities.  In the meantime, I'll give additional insights building on Ian's great comments regarding Pre-Approval Inspections (PAI) and their focus on PMA devices rather than 510(k) devices.

Namely, two key U.S. premarket pathways for medical devices are FD&C Act section 510(k) (premarket notification and "clearance") and section 515 (premarket "approval").  Their unique intrinsic statutory purposes are what drive FDA's pursuit (or lack thereof) of premarket / preapproval inspection.

Specifically, the statutory basis of section 510(k) is generally aimed at determining "substantial equivalence" of the subject device, which means, with respect to a legally marketed predicate device, that the subject device has the same intended use as the predicate device and that it either (i) has the same technological characteristics as the predicate device, or (ii)(I) has different technological characteristics that don't raise different questions of safety and effectiveness than the predicate device.  In general, premarket FDA inspection is not generally deemed necessary for meeting the statutory substantial equivalence ("clearance") threshold.  Indeed, only a few aspects of the subject device's GMPs, if any at all, are addressed in a 510(k) notification.  This pathway is most typically used for Class II devices, but also for Class I devices that are not 510(k)-exempt, and some Class III devices that don't require PMA.

In contrast, the basis of section 515 is "approval" of the subject device.  It is reserved for Class III devices.  One of multiple statutory thresholds for premarket "approval" (PMA) is conformity with GMP [see sections 515(d)(2)(C) and 520(f) of the FD&C Act].  Accordingly, FDA performs PAIs for PMA devices before granting premarket approval of the subject device.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 25-Jan-2023 04:52
From: Richard Jansky
Subject: FDA pre-approval inspections

Dear all

I fail to understand when FDA pre-approval inspections can occur. The sources I found say that they occur after the company submits an application to market a new product. In some cases they specifically refer to PMA (Premarket Approval Application). In other cases they imply that it is needed for any new product not on the market yet.

In my case I would like to place a product on the US market, the type of which has an existing regulation number and is exempt from the 510(k). Thus, there are similar products by other brands on the US market already. Am I to expect an FDA pre-approval inspection once I submit the application to place our product on the market?

Thank you so much for your clarification.

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Hi Richard,

If your device is class II then yes, you can expect routine inspections. Richard Vincins' response gives a good summary of this applicable inspection possibility and resource limitations within the FDA to carry out these types of inspections.

------------------------------
Ian Boland
Regulatory Affairs Specialist
NJ
United States
------------------------------

Original Message:
Sent: 26-Jan-2023 06:01
From: Richard Jansky
Subject: FDA pre-approval inspections

Thank you Ian, Kevin, and Richard for your insights! That is very helpful.

One clarification to Ian: Our device is 510(k) exempt, but class II. Thus, in addition to the "for cause" inspections, we can also expect routine and potentially follow-up inspections, correct?

To Kevin: In retrospect I believe the sources are correct. It is my misinterpretation of the term "new product" as they must mean "an unapproved product". One example is "Pre-approval inspections are conducted on all new products. Once an application to introduce a new product to market is submitted, the FDA will make an inspection."

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 26-Jan-2023 04:09
From: Richard Vincins
Subject: FDA pre-approval inspections

Hello Richard,

A Pre-Approval Inspection or PAI is only required with a Pre-Market Approval (PMA) submission through the US FDA https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-contents (and also reference the various guidance documents).  Well I should say generally only required.  If a De Novo submission is made and happens to fall into the Class III/PMA area - well still being a PMA - then would require a PAI.  For other Class II and I devices, including 510(k) Exempt) products, an inspection is performed routinely according to the compliance requirements and the regulations.  It is by law they have to inspect every two years, but this does not happen due to the sheer numbers of manufacturers (one of the changes supposedly being introduced using risk-based approach on inspections when they overhaul the Quality System Regulation).  If your device is 510(k) Exempt, then when your establishment is registered this allows the US FDA to inspect your facility at any time; but for 510(k) Exempt devices there is no PAI done.  It does not mean the FDA may not show up 1 month after your establishment is registered or they could show up 5 years later ... but they can perform an inspection at any time.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 25-Jan-2023 12:49
From: Kevin Randall
Subject: FDA pre-approval inspections

Hi Richard,

It would be helpful for us to see your sources, as their contexts could shed more light on potential ambiguities.  In the meantime, I'll give additional insights building on Ian's great comments regarding Pre-Approval Inspections (PAI) and their focus on PMA devices rather than 510(k) devices.

Namely, two key U.S. premarket pathways for medical devices are FD&C Act section 510(k) (premarket notification and "clearance") and section 515 (premarket "approval").  Their unique intrinsic statutory purposes are what drive FDA's pursuit (or lack thereof) of premarket / preapproval inspection.

Specifically, the statutory basis of section 510(k) is generally aimed at determining "substantial equivalence" of the subject device, which means, with respect to a legally marketed predicate device, that the subject device has the same intended use as the predicate device and that it either (i) has the same technological characteristics as the predicate device, or (ii)(I) has different technological characteristics that don't raise different questions of safety and effectiveness than the predicate device.  In general, premarket FDA inspection is not generally deemed necessary for meeting the statutory substantial equivalence ("clearance") threshold.  Indeed, only a few aspects of the subject device's GMPs, if any at all, are addressed in a 510(k) notification.  This pathway is most typically used for Class II devices, but also for Class I devices that are not 510(k)-exempt, and some Class III devices that don't require PMA.

In contrast, the basis of section 515 is "approval" of the subject device.  It is reserved for Class III devices.  One of multiple statutory thresholds for premarket "approval" (PMA) is conformity with GMP [see sections 515(d)(2)(C) and 520(f) of the FD&C Act].  Accordingly, FDA performs PAIs for PMA devices before granting premarket approval of the subject device.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 25-Jan-2023 04:52
From: Richard Jansky
Subject: FDA pre-approval inspections

Dear all

I fail to understand when FDA pre-approval inspections can occur. The sources I found say that they occur after the company submits an application to market a new product. In some cases they specifically refer to PMA (Premarket Approval Application). In other cases they imply that it is needed for any new product not on the market yet.

In my case I would like to place a product on the US market, the type of which has an existing regulation number and is exempt from the 510(k). Thus, there are similar products by other brands on the US market already. Am I to expect an FDA pre-approval inspection once I submit the application to place our product on the market?

Thank you so much for your clarification.

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

Our device is class II.  The 510(k) focuses on the device design and testing. The inpsection focuses on the outputs of your QMS but CAPA, NC are usually checked. We recently had an RRA due to COVID but FDA implied thesee remote inspection may be here to stay for lower risk devices with no complaints to them.​

------------------------------
Edward Panek
VP, QA/RA
Med Device
USN Veteran
Research into Neural Nets - https://www.twitch.tv/edosani
------------------------------

Original Message:
Sent: 26-Jan-2023 09:12
From: Ian Boland
Subject: FDA pre-approval inspections

Hi Richard,

If your device is class II then yes, you can expect routine inspections. Richard Vincins' response gives a good summary of this applicable inspection possibility and resource limitations within the FDA to carry out these types of inspections.

------------------------------
Ian Boland
Regulatory Affairs Specialist
NJ
United States

Original Message:
Sent: 26-Jan-2023 06:01
From: Richard Jansky
Subject: FDA pre-approval inspections

Thank you Ian, Kevin, and Richard for your insights! That is very helpful.

One clarification to Ian: Our device is 510(k) exempt, but class II. Thus, in addition to the "for cause" inspections, we can also expect routine and potentially follow-up inspections, correct?

To Kevin: In retrospect I believe the sources are correct. It is my misinterpretation of the term "new product" as they must mean "an unapproved product". One example is "Pre-approval inspections are conducted on all new products. Once an application to introduce a new product to market is submitted, the FDA will make an inspection."

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 26-Jan-2023 04:09
From: Richard Vincins
Subject: FDA pre-approval inspections

Hello Richard,

A Pre-Approval Inspection or PAI is only required with a Pre-Market Approval (PMA) submission through the US FDA https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-contents (and also reference the various guidance documents).  Well I should say generally only required.  If a De Novo submission is made and happens to fall into the Class III/PMA area - well still being a PMA - then would require a PAI.  For other Class II and I devices, including 510(k) Exempt) products, an inspection is performed routinely according to the compliance requirements and the regulations.  It is by law they have to inspect every two years, but this does not happen due to the sheer numbers of manufacturers (one of the changes supposedly being introduced using risk-based approach on inspections when they overhaul the Quality System Regulation).  If your device is 510(k) Exempt, then when your establishment is registered this allows the US FDA to inspect your facility at any time; but for 510(k) Exempt devices there is no PAI done.  It does not mean the FDA may not show up 1 month after your establishment is registered or they could show up 5 years later ... but they can perform an inspection at any time.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 25-Jan-2023 12:49
From: Kevin Randall
Subject: FDA pre-approval inspections

Hi Richard,

It would be helpful for us to see your sources, as their contexts could shed more light on potential ambiguities.  In the meantime, I'll give additional insights building on Ian's great comments regarding Pre-Approval Inspections (PAI) and their focus on PMA devices rather than 510(k) devices.

Namely, two key U.S. premarket pathways for medical devices are FD&C Act section 510(k) (premarket notification and "clearance") and section 515 (premarket "approval").  Their unique intrinsic statutory purposes are what drive FDA's pursuit (or lack thereof) of premarket / preapproval inspection.

Specifically, the statutory basis of section 510(k) is generally aimed at determining "substantial equivalence" of the subject device, which means, with respect to a legally marketed predicate device, that the subject device has the same intended use as the predicate device and that it either (i) has the same technological characteristics as the predicate device, or (ii)(I) has different technological characteristics that don't raise different questions of safety and effectiveness than the predicate device.  In general, premarket FDA inspection is not generally deemed necessary for meeting the statutory substantial equivalence ("clearance") threshold.  Indeed, only a few aspects of the subject device's GMPs, if any at all, are addressed in a 510(k) notification.  This pathway is most typically used for Class II devices, but also for Class I devices that are not 510(k)-exempt, and some Class III devices that don't require PMA.

In contrast, the basis of section 515 is "approval" of the subject device.  It is reserved for Class III devices.  One of multiple statutory thresholds for premarket "approval" (PMA) is conformity with GMP [see sections 515(d)(2)(C) and 520(f) of the FD&C Act].  Accordingly, FDA performs PAIs for PMA devices before granting premarket approval of the subject device.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 25-Jan-2023 04:52
From: Richard Jansky
Subject: FDA pre-approval inspections

Dear all

I fail to understand when FDA pre-approval inspections can occur. The sources I found say that they occur after the company submits an application to market a new product. In some cases they specifically refer to PMA (Premarket Approval Application). In other cases they imply that it is needed for any new product not on the market yet.

In my case I would like to place a product on the US market, the type of which has an existing regulation number and is exempt from the 510(k). Thus, there are similar products by other brands on the US market already. Am I to expect an FDA pre-approval inspection once I submit the application to place our product on the market?

Thank you so much for your clarification.

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------

------------------------------
Ginger Cantor, MBA, RAC
Founder/Principal Consultant
Centaur Consulting LLC
River Falls, Wisconsin 54022 USA
715-307-1850
centaurconsultingllc@gmail.com
------------------------------

Original Message:
Sent: 26-Jan-2023 06:01
From: Richard Jansky
Subject: FDA pre-approval inspections

Thank you Ian, Kevin, and Richard for your insights! That is very helpful.

One clarification to Ian: Our device is 510(k) exempt, but class II. Thus, in addition to the "for cause" inspections, we can also expect routine and potentially follow-up inspections, correct?

To Kevin: In retrospect I believe the sources are correct. It is my misinterpretation of the term "new product" as they must mean "an unapproved product". One example is "Pre-approval inspections are conducted on all new products. Once an application to introduce a new product to market is submitted, the FDA will make an inspection."

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland

Original Message:
Sent: 26-Jan-2023 04:09
From: Richard Vincins
Subject: FDA pre-approval inspections

Hello Richard,

A Pre-Approval Inspection or PAI is only required with a Pre-Market Approval (PMA) submission through the US FDA https://www.fda.gov/medical-devices/premarket-approval-pma/pma-application-contents (and also reference the various guidance documents).  Well I should say generally only required.  If a De Novo submission is made and happens to fall into the Class III/PMA area - well still being a PMA - then would require a PAI.  For other Class II and I devices, including 510(k) Exempt) products, an inspection is performed routinely according to the compliance requirements and the regulations.  It is by law they have to inspect every two years, but this does not happen due to the sheer numbers of manufacturers (one of the changes supposedly being introduced using risk-based approach on inspections when they overhaul the Quality System Regulation).  If your device is 510(k) Exempt, then when your establishment is registered this allows the US FDA to inspect your facility at any time; but for 510(k) Exempt devices there is no PAI done.  It does not mean the FDA may not show up 1 month after your establishment is registered or they could show up 5 years later ... but they can perform an inspection at any time.

------------------------------
Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs

Original Message:
Sent: 25-Jan-2023 12:49
From: Kevin Randall
Subject: FDA pre-approval inspections

Hi Richard,

It would be helpful for us to see your sources, as their contexts could shed more light on potential ambiguities.  In the meantime, I'll give additional insights building on Ian's great comments regarding Pre-Approval Inspections (PAI) and their focus on PMA devices rather than 510(k) devices.

Namely, two key U.S. premarket pathways for medical devices are FD&C Act section 510(k) (premarket notification and "clearance") and section 515 (premarket "approval").  Their unique intrinsic statutory purposes are what drive FDA's pursuit (or lack thereof) of premarket / preapproval inspection.

Specifically, the statutory basis of section 510(k) is generally aimed at determining "substantial equivalence" of the subject device, which means, with respect to a legally marketed predicate device, that the subject device has the same intended use as the predicate device and that it either (i) has the same technological characteristics as the predicate device, or (ii)(I) has different technological characteristics that don't raise different questions of safety and effectiveness than the predicate device.  In general, premarket FDA inspection is not generally deemed necessary for meeting the statutory substantial equivalence ("clearance") threshold.  Indeed, only a few aspects of the subject device's GMPs, if any at all, are addressed in a 510(k) notification.  This pathway is most typically used for Class II devices, but also for Class I devices that are not 510(k)-exempt, and some Class III devices that don't require PMA.

In contrast, the basis of section 515 is "approval" of the subject device.  It is reserved for Class III devices.  One of multiple statutory thresholds for premarket "approval" (PMA) is conformity with GMP [see sections 515(d)(2)(C) and 520(f) of the FD&C Act].  Accordingly, FDA performs PAIs for PMA devices before granting premarket approval of the subject device.

------------------------------
Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
© Copyright 2023 by ComplianceAcuity, Inc. All rights reserved.

Original Message:
Sent: 25-Jan-2023 04:52
From: Richard Jansky
Subject: FDA pre-approval inspections

Dear all

I fail to understand when FDA pre-approval inspections can occur. The sources I found say that they occur after the company submits an application to market a new product. In some cases they specifically refer to PMA (Premarket Approval Application). In other cases they imply that it is needed for any new product not on the market yet.

In my case I would like to place a product on the US market, the type of which has an existing regulation number and is exempt from the 510(k). Thus, there are similar products by other brands on the US market already. Am I to expect an FDA pre-approval inspection once I submit the application to place our product on the market?

Thank you so much for your clarification.

------------------------------
Richard Jansky
Head of RA / RM / QM
Beringen
Switzerland
------------------------------