Regulatory Open Forum

Dear All,

Good day.

Currently we have a customer with product 510(k) registered with Gamma Ray Sterilization. Recently they made decision to change sterilization method from Gamma Ray to EtO sterilization.

May i know do they need to resubmit for the 510(k)? or a notification of change / amendment of registration is sufficient for them to market in US with the sterilization validation done and proved effective to achieve SAL 10-6?

Please advice。

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Ok, I will try this again:

In 1997, the Center for Devices and Radiological Health (CDRH) decided that, given a manufacturer's obligation to comply with the QS requirements, the safety and effectiveness of a device manufacturer's sterilization process would best be ensured through compliance with the QS regulation rather than through 510(k) review. This decision was communicated to ODE staff and the medical device industry in Blue Book Memorandum #K97-1 entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device."¹ In this guidance, CDRH stated that manufacturers may modify existing devices in a number of ways, including labeling changes, technology or performance specification changes, and materials changes without submitting a new 510(k) unless 'a change or the sum of the incremental changes exceeds the section 807.81⁴(a)(3) threshold, "could significantly affect the safety or effectiveness of the device."' CDRH included changes in the sterilization method as a type of change that would not normally trip the regulatory threshold for submission of a new 510(k). As stated in the guidance, changes in sterilization processes do not require 510(k) clearance, unless the changes significantly alter the properties/specifications of a device or result in a lower sterility assurance level (SAL). In instances where a manufacturer concludes that a change in sterilization method has not significantly affected device properties/specifications or resulted in a lower SAL, no 510(k) need be submitted. Rather, the appropriate documentation must be maintained at the manufacturing site in accordance with the QS regulation requirements.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072783.htm

-------------------------------------------
John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:08
From: Winson Teng
Subject: Changing of Sterilization Method

Dear All,

Good day.

Currently we have a customer with product 510(k) registered with Gamma Ray Sterilization. Recently they made decision to change sterilization method from Gamma Ray to EtO sterilization.

May i know do they need to resubmit for the 510(k)? or a notification of change / amendment of registration is sufficient for them to market in US with the sterilization validation done and proved effective to achieve SAL 10-6?

Please advice。

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Dear John,

Thank you very much on your kind help and advice on this issue.
Appreciate a lot on the support links. It is very helpful.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------


Original Message:
Sent: 11-13-2014 07:57
From: John Lay
Subject: Changing of Sterilization Method

Ok, I will try this again:

In 1997, the Center for Devices and Radiological Health (CDRH) decided that, given a manufacturer's obligation to comply with the QS requirements, the safety and effectiveness of a device manufacturer's sterilization process would best be ensured through compliance with the QS regulation rather than through 510(k) review. This decision was communicated to ODE staff and the medical device industry in Blue Book Memorandum #K97-1 entitled, "Deciding When to Submit a 510(k) for a Change to an Existing Device."¹ In this guidance, CDRH stated that manufacturers may modify existing devices in a number of ways, including labeling changes, technology or performance specification changes, and materials changes without submitting a new 510(k) unless 'a change or the sum of the incremental changes exceeds the section 807.81⁴(a)(3) threshold, "could significantly affect the safety or effectiveness of the device."' CDRH included changes in the sterilization method as a type of change that would not normally trip the regulatory threshold for submission of a new 510(k). As stated in the guidance, changes in sterilization processes do not require 510(k) clearance, unless the changes significantly alter the properties/specifications of a device or result in a lower sterility assurance level (SAL). In instances where a manufacturer concludes that a change in sterilization method has not significantly affected device properties/specifications or resulted in a lower SAL, no 510(k) need be submitted. Rather, the appropriate documentation must be maintained at the manufacturing site in accordance with the QS regulation requirements.

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm072783.htm

-------------------------------------------
John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:08
From: Winson Teng
Subject: Changing of Sterilization Method

Dear All,

Good day.

Currently we have a customer with product 510(k) registered with Gamma Ray Sterilization. Recently they made decision to change sterilization method from Gamma Ray to EtO sterilization.

May i know do they need to resubmit for the 510(k)? or a notification of change / amendment of registration is sufficient for them to market in US with the sterilization validation done and proved effective to achieve SAL 10-6?

Please advice。

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Dear Winson,

FDA guidance states:

Has there been a change in sterilization? Changes in sterilization have the potential for affecting the safety or effectiveness of the device and, thus, must be carefully assessed. Changes which have a lower sterility assurance level (SAL) would routinely need a new 510(k) as would those which ordinarily affect the integrity of device materials.

 

Has there been a change in performance specification of the device or in the sterility assurance level attained as a result of the change in sterilization? Changes in the method of sterilization have the potential for changing performance characteristics of a device. This is particularly true of the properties of polymeric materials. When manufacturers make changes in sterilization methods, they must document that the important properties/specifications of the device remain unaffected. In addition, if the SAL is lowered, manufacturers must consider whether device safety or effectiveness may have been compromised by the new level. In general, reductions in SAL should trigger 510(k) submissions unless the SAL remains above 10-6. In any event, manufacturers need to assess critically the need for a new 510(k) for their device in these instances.

-------------------------------------------
Carroll Hoyle
Sr. Global Regulatory Affairs
BSN Medical
Rutherford College NC
United States
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:08
From: Winson Teng
Subject: Changing of Sterilization Method

Dear All,

Good day.

Currently we have a customer with product 510(k) registered with Gamma Ray Sterilization. Recently they made decision to change sterilization method from Gamma Ray to EtO sterilization.

May i know do they need to resubmit for the 510(k)? or a notification of change / amendment of registration is sufficient for them to market in US with the sterilization validation done and proved effective to achieve SAL 10-6?

Please advice。

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Dear Carroll,

Good day.
Thank you for your advice. It is clear and i am know what i should proceed with the next steps.

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------


Original Message:
Sent: 11-13-2014 08:46
From: Carroll Hoyle
Subject: Changing of Sterilization Method

Dear Winson,

FDA guidance states:

Has there been a change in sterilization? Changes in sterilization have the potential for affecting the safety or effectiveness of the device and, thus, must be carefully assessed. Changes which have a lower sterility assurance level (SAL) would routinely need a new 510(k) as would those which ordinarily affect the integrity of device materials.

 

Has there been a change in performance specification of the device or in the sterility assurance level attained as a result of the change in sterilization? Changes in the method of sterilization have the potential for changing performance characteristics of a device. This is particularly true of the properties of polymeric materials. When manufacturers make changes in sterilization methods, they must document that the important properties/specifications of the device remain unaffected. In addition, if the SAL is lowered, manufacturers must consider whether device safety or effectiveness may have been compromised by the new level. In general, reductions in SAL should trigger 510(k) submissions unless the SAL remains above 10-6. In any event, manufacturers need to assess critically the need for a new 510(k) for their device in these instances.

-------------------------------------------
Carroll Hoyle
Sr. Global Regulatory Affairs
BSN Medical
Rutherford College NC
United States
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:08
From: Winson Teng
Subject: Changing of Sterilization Method

Dear All,

Good day.

Currently we have a customer with product 510(k) registered with Gamma Ray Sterilization. Recently they made decision to change sterilization method from Gamma Ray to EtO sterilization.

May i know do they need to resubmit for the 510(k)? or a notification of change / amendment of registration is sufficient for them to market in US with the sterilization validation done and proved effective to achieve SAL 10-6?

Please advice。

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Hi Winson,

I would suggest that the sterilization modification would fall under a Special 510(k) as it appears that this would not or does not change the intended use or alter its fundamental scientific technology. The Special 510(k) should clearly state that intended use of the modified device has not changed as a result of the modification.  The sterilization change would require appropriate change control in the DMR and DHF. 

Hope this is useful,

Dar

-------------------------------------------
Darlene Rosario RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:08
From: Winson Teng
Subject: Changing of Sterilization Method

Dear All,

Good day.

Currently we have a customer with product 510(k) registered with Gamma Ray Sterilization. Recently they made decision to change sterilization method from Gamma Ray to EtO sterilization.

May i know do they need to resubmit for the 510(k)? or a notification of change / amendment of registration is sufficient for them to market in US with the sterilization validation done and proved effective to achieve SAL 10-6?

Please advice。

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

 As stated in the guidance, changes in sterilization processes do not require 510(k) clearance, unless the changes significantly alter the properties/specifications of a device or result in a lower sterility assurance level (SAL). In instances where a manufacturer concludes that a change in sterilization method has not significantly affected device properties/specifications or resulted in a lower SAL, no 510(k) need be submitted. Rather, the appropriate documentation must be maintained at the manufacturing site in accordance with the QS regulation requirements.

I hope this puts this question to rest, FDA is rather clear on this issue.

-------------------------------------------
John Lay
Director, Regulatory and Quality
Vistapharm Inc.
Largo FL
United States
-------------------------------------------


Original Message:
Sent: 11-13-2014 10:18
From: Darlene Rosario
Subject: Changing of Sterilization Method

Hi Winson,

I would suggest that the sterilization modification would fall under a Special 510(k) as it appears that this would not or does not change the intended use or alter its fundamental scientific technology. The Special 510(k) should clearly state that intended use of the modified device has not changed as a result of the modification.  The sterilization change would require appropriate change control in the DMR and DHF. 

Hope this is useful,

Dar

-------------------------------------------
Darlene Rosario RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:08
From: Winson Teng
Subject: Changing of Sterilization Method

Dear All,

Good day.

Currently we have a customer with product 510(k) registered with Gamma Ray Sterilization. Recently they made decision to change sterilization method from Gamma Ray to EtO sterilization.

May i know do they need to resubmit for the 510(k)? or a notification of change / amendment of registration is sufficient for them to market in US with the sterilization validation done and proved effective to achieve SAL 10-6?

Please advice。

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Dear Darlene,

It is helpful! Thank you for your kind guidance.
Appreciate that!

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------


Original Message:
Sent: 11-13-2014 10:18
From: Darlene Rosario
Subject: Changing of Sterilization Method

Hi Winson,

I would suggest that the sterilization modification would fall under a Special 510(k) as it appears that this would not or does not change the intended use or alter its fundamental scientific technology. The Special 510(k) should clearly state that intended use of the modified device has not changed as a result of the modification.  The sterilization change would require appropriate change control in the DMR and DHF. 

Hope this is useful,

Dar

-------------------------------------------
Darlene Rosario RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:08
From: Winson Teng
Subject: Changing of Sterilization Method

Dear All,

Good day.

Currently we have a customer with product 510(k) registered with Gamma Ray Sterilization. Recently they made decision to change sterilization method from Gamma Ray to EtO sterilization.

May i know do they need to resubmit for the 510(k)? or a notification of change / amendment of registration is sufficient for them to market in US with the sterilization validation done and proved effective to achieve SAL 10-6?

Please advice。

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------

Hello Winson -

I agree with John and do not see this as something that triggers the need for a new 510(k).  Based on my experience, as long as your client documents a thorough assessment of this change, referencing any data collected that demonstrates that it does not negatively impact the device (in comparison to the previous method), they should be okay should FDA question this change.  It's all about demonstrating that the company considered all potential impacts on the device AND whether the changes impact the safety and efficacy of the device.  I believe that a well-documented rationale for no new 510(k) could mean the difference, in a worst case scenario, between enforcement action and FDA allowing marketing of the device to continue while a requested submission is under review.

With all of that said, whether to submit a new 510(k) also comes down to the risk tolerance of the company - a risk averse company may choose to submit a Special 510(k) just to be "safe," although that's not what I would recommend.  

-------------------------------------------
Laurie Cartwright
Senior Manager II, Regulatory Affairs
Smith & Nephew (formerly ArthroCare Corporation)
Irvine CA
United States
-------------------------------------------


Original Message:
Sent: 11-13-2014 20:52
From: Winson Teng
Subject: Changing of Sterilization Method

Dear Darlene,

It is helpful! Thank you for your kind guidance.
Appreciate that!

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------


Original Message:
Sent: 11-13-2014 10:18
From: Darlene Rosario
Subject: Changing of Sterilization Method

Hi Winson,

I would suggest that the sterilization modification would fall under a Special 510(k) as it appears that this would not or does not change the intended use or alter its fundamental scientific technology. The Special 510(k) should clearly state that intended use of the modified device has not changed as a result of the modification.  The sterilization change would require appropriate change control in the DMR and DHF. 

Hope this is useful,

Dar

-------------------------------------------
Darlene Rosario RAC
Principal Consultant RA, Quality and Compliance
Velocity Consulting
Ventura CA
United States
-------------------------------------------


Original Message:
Sent: 11-12-2014 20:08
From: Winson Teng
Subject: Changing of Sterilization Method

Dear All,

Good day.

Currently we have a customer with product 510(k) registered with Gamma Ray Sterilization. Recently they made decision to change sterilization method from Gamma Ray to EtO sterilization.

May i know do they need to resubmit for the 510(k)? or a notification of change / amendment of registration is sufficient for them to market in US with the sterilization validation done and proved effective to achieve SAL 10-6?

Please advice。

Thank you.

-------------------------------------------
Winson Teng
Regulatory Affairs Engineer
Singapore
-------------------------------------------