Regulatory Open Forum

If the FDA performs an administrative review of a Special 510(k) as part of the RTA process, and decides that the submission fulfills the requirements/criteria of a Special 510(k), can it happen that during the course of the substantive review, the FDA may decide that the submission should be a Traditional? In other words, is the FDA "bound" by its finding at the stage of the RTA administrative review?   

-------------------------------------------
Asher Kassel
Lifewatch Technologies Ltd.
Rehovot
Israel
-------------------------------------------

Yes.

Please refer to http://wp.me/P33LGu-3o3 

"If the file is converted from a special to a traditional after the 15 calendar day acceptance review period, any missing information that would have resulted in RTA designation should be obtained during the substantive review."

It should be construed as if the FDA is NOT bound as reflected in the said guidance.  

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 10-19-2014 01:47
From: Asher Kassel
Subject: FDA policy on RTA (Refuse to Accept)

If the FDA performs an administrative review of a Special 510(k) as part of the RTA process, and decides that the submission fulfills the requirements/criteria of a Special 510(k), can it happen that during the course of the substantive review, the FDA may decide that the submission should be a Traditional? In other words, is the FDA "bound" by its finding at the stage of the RTA administrative review?   

-------------------------------------------
Asher Kassel
Lifewatch Technologies Ltd.
Rehovot
Israel
-------------------------------------------

"Yes" was meant to mean that FDA can convert from a special to a traditional 510(k) before or after the RTA admin review.  


Original Message:
Sent: 10-19-2014 14:29
From: David Lim
Subject: FDA policy on RTA (Refuse to Accept)

Yes.

Please refer to http://wp.me/P33LGu-3o3 

"If the file is converted from a special to a traditional after the 15 calendar day acceptance review period, any missing information that would have resulted in RTA designation should be obtained during the substantive review."

It should be construed as if the FDA is NOT bound as reflected in the said guidance.  

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 

President and CEO | REGULATORY DOCTOR
Phone (Toll-Free): 1-(800) 321-8567

Direct-dial: (540) 763-3333

Fax: (866) 591-5671

E-mail:  David@RegulatoryDoctor.com

- About What I Do at https://www.youtube.com/watch?v=W_HOyfNaQVE#t=90

- About Regulatory Doctor at https://www.youtube.com/watch?v=QegpaHXlfqQ or https://www.youtube.com/watch?v=tHlOzqQXNg8

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- Providing global and FDA compliance seminars at http://www.globalcomplianceseminar.com

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"Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

Original Message:
Sent: 10-19-2014 01:47
From: Asher Kassel
Subject: FDA policy on RTA (Refuse to Accept)

If the FDA performs an administrative review of a Special 510(k) as part of the RTA process, and decides that the submission fulfills the requirements/criteria of a Special 510(k), can it happen that during the course of the substantive review, the FDA may decide that the submission should be a Traditional? In other words, is the FDA "bound" by its finding at the stage of the RTA administrative review?   

-------------------------------------------
Asher Kassel
Lifewatch Technologies Ltd.
Rehovot
Israel
-------------------------------------------

I do not believe this is accurate. I recently attended a seminar at RAPS about the 510(k) process and the speaker from FDA (name escapes me at the moment) said that if the FDA accepts a Special 510(k) as part of the RTA, they cannot officially convert it later. They may decide to ask for more information during the substantive review but FDA would have to "eat the extra time". Thus theY still only have 30 days instead of 90 days to make their decision, but you will likely have more clock stops. KAM ------------------------------------------- Kerri-Anne Mallet K-Med Regulatory Services Attleboro MA United States -------------------------------------------
Original Message: Sent: 10-19-2014 14:33 From: David Lim Subject: FDA policy on RTA (Refuse to Accept) "Yes" was meant to mean that FDA can convert from a special to a traditional 510(k) before or after the RTA admin review.
Original Message: Sent: 10-19-2014 14:29 From: David Lim Subject: FDA policy on RTA (Refuse to Accept) Yes. Please refer to http://wp.me/P33LGu-3o3 "If the file is converted from a special to a traditional after the 15 calendar day acceptance review period, any missing information that would have resulted in RTA designation should be obtained during the substantive review." It should be construed as if the FDA is NOT bound as reflected in the said guidance. ____________________________________________________________ Dr. David Lim, Ph.D., RAC, ASQ-CQA President and CEO | REGULATORY DOCTOR <http://regulatorydoctor.com/our-team-regulatory-doctor-david-lim/> Phone (Toll-Free): 1-(800) 321-8567 Direct-dial: (540) 763-3333 Fax: (866) 591-5671 E-mail: David@RegulatoryDoctor.com - About What I Do at https://www.youtube.com/watch?v=W_HOyfNaQVE#t=90 <https://www.youtube.com/watch?v=W_HOyfNaQVE#t=90> - About Regulatory Doctor at https://www.youtube.com/watch?v=QegpaHXlfqQ <https://www.youtube.com/watch?v=QegpaHXlfqQ> or https://www.youtube.com/watch?v=tHlOzqQXNg8 <https://www.youtube.com/watch?v=tHlOzqQXNg8> - You may book an appointment at http://www.vcita.com/v/regulatorydr <http://www.vcita.com/v/regulatorydr> - Providing global and FDA compliance seminars at http://www.globalcomplianceseminar.com <http://www.globalcomplianceseminar.com/> - QR Code <http://qrfree.kaywa.com/?l=1&s=8&d=SMSTO:540-315-7221%3AThank+you%21+David> "Knowledge is power only when it is practiced and put into action." - Regulatory Doctor
Original Message: Sent: 10-19-2014 01:47 From: Asher Kassel Subject: FDA policy on RTA (Refuse to Accept) If the FDA performs an administrative review of a Special 510(k) as part of the RTA process, and decides that the submission fulfills the requirements/criteria of a Special 510(k), can it happen that during the course of the substantive review, the FDA may decide that the submission should be a Traditional? In other words, is the FDA "bound" by its finding at the stage of the RTA administrative review? ------------------------------------------- Asher Kassel Lifewatch Technologies Ltd. Rehovot Israel -------------------------------------------

I agree with KAM, that FDA cannot convert its decission.
Geeta Pamidimukkala from FDA had this talk at RAPS 2014 about it. I could not find it in her slides, so maybe it was a question after her talk. If you have access to the web content of RAPS 2014 there is a video from this session. You might find it there.

Best,
Dirk


-------------------------------------------
Dirk Steinhoff
Regulatory Affairs Manage
Volketswil
Switzerland
-------------------------------------------


Original Message:
Sent: 10-20-2014 08:12
From: Kerri-Anne Mallet
Subject: FDA policy on RTA (Refuse to Accept)

I do not believe this is accurate. I recently attended a seminar at RAPS about the 510(k) process and the speaker from FDA (name escapes me at the moment) said that if the FDA accepts a Special 510(k) as part of the RTA, they cannot officially convert it later. They may decide to ask for more information during the substantive review but FDA would have to "eat the extra time". Thus theY still only have 30 days instead of 90 days to make their decision, but you will likely have more clock stops.

KAM


-------------------------------------------
Kerri-Anne Mallet
K-Med Regulatory Services
Attleboro MA
United States
-------------------------------------------

I can share practical cases.

1). A firm may present their device design modification as a special 510(k). During an RTA review, it was accepted as a special 510(k).  During the substantive review, the reviewer may realize that there are some design changes that trigger/broaden the intended use/indications.  

Would you choose to receive an NSE letter and then submit a new traditional 510(k) with another fee?

OR

Would you rather convert your special 510(k) to a traditional without paying an additional fee?

2). After the RTA review as a special 510(k), the reviewer realized during the substantive review that the additional data submitted by a firm during the substantive review significantly constitute performance data not merely supporting compliance to the previous design/performance of the device.  If this is the case, the reviewer has to convert from a special 510(k) to a traditional 510(k) review process.  

If an RTA review is bound (even administratively only and not legally), this is a big loophole for abusive practices - firms can submit as special 510(k)s for design modifications while attempting to slightly broaden the scope and meaning of the intended use/indications during the substantive review.

Please note: the FDA reviewers shouldn't deviate from the guidance(s) without reasonable justification. Read more at https://www.linkedin.com/pulse/article/20140514134039-19369535-understanding-the-meaning-and-scope-of-fda-guidance

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 


Original Message:
Sent: 10-20-2014 09:25
From: Dirk Steinhoff
Subject: FDA policy on RTA (Refuse to Accept)

I agree with KAM, that FDA cannot convert its decission.
Geeta Pamidimukkala from FDA had this talk at RAPS 2014 about it. I could not find it in her slides, so maybe it was a question after her talk. If you have access to the web content of RAPS 2014 there is a video from this session. You might find it there.

Best,
Dirk


-------------------------------------------
Dirk Steinhoff
Regulatory Affairs Manage
Volketswil
Switzerland
-------------------------------------------


Original Message:
Sent: 10-20-2014 08:12
From: Kerri-Anne Mallet
Subject: FDA policy on RTA (Refuse to Accept)

I do not believe this is accurate. I recently attended a seminar at RAPS about the 510(k) process and the speaker from FDA (name escapes me at the moment) said that if the FDA accepts a Special 510(k) as part of the RTA, they cannot officially convert it later. They may decide to ask for more information during the substantive review but FDA would have to "eat the extra time". Thus theY still only have 30 days instead of 90 days to make their decision, but you will likely have more clock stops.

KAM


-------------------------------------------
Kerri-Anne Mallet
K-Med Regulatory Services
Attleboro MA
United States
-------------------------------------------

But we have to be aware of the following though:

For the purpose of preventing FDA reviewers from blowing "hot" or "cold" air anytime during the review process, it should be bound in this sense.

As for the purpose of accurately assessing the device's substantial equivalence in view of 1). intended use and 2). technological characteristics, etc., it shouldn't be construed as bound. 


Original Message:
Sent: 10-20-2014 11:31
From: David Lim
Subject: FDA policy on RTA (Refuse to Accept)

I can share practical cases.

1). A firm may present their device design modification as a special 510(k). During an RTA review, it was accepted as a special 510(k).  During the substantive review, the reviewer may realize that there are some design changes that trigger/broaden the intended use/indications.  

Would you choose to receive an NSE letter and then submit a new traditional 510(k) with another fee?

OR

Would you rather convert your special 510(k) to a traditional without paying an additional fee?

2). After the RTA review as a special 510(k), the reviewer realized during the substantive review that the additional data submitted by a firm during the substantive review significantly constitute performance data not merely supporting compliance to the previous design/performance of the device.  If this is the case, the reviewer has to convert from a special 510(k) to a traditional 510(k) review process.  

If an RTA review is bound (even administratively only and not legally), this is a big loophole for abusive practices - firms can submit as special 510(k)s for design modifications while attempting to slightly broaden the scope and meaning of the intended use/indications during the substantive review.

Please note: the FDA reviewers shouldn't deviate from the guidance(s) without reasonable justification. Read more at https://www.linkedin.com/pulse/article/20140514134039-19369535-understanding-the-meaning-and-scope-of-fda-guidance

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 

President and CEO | REGULATORY DOCTOR
Phone (Toll-Free): 1-(800) 321-8567

Direct-dial: (540) 763-3333

Fax: (866) 591-5671

E-mail:  David@RegulatoryDoctor.com

- About What I Do at https://www.youtube.com/watch?v=W_HOyfNaQVE#t=90

- About Regulatory Doctor at https://www.youtube.com/watch?v=QegpaHXlfqQ or https://www.youtube.com/watch?v=tHlOzqQXNg8

- You may book an appointment at http://www.vcita.com/v/regulatorydr

- Providing global and FDA compliance seminars at http://www.globalcomplianceseminar.com

- QR Code

"Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

Original Message:
Sent: 10-20-2014 09:25
From: Dirk Steinhoff
Subject: FDA policy on RTA (Refuse to Accept)

I agree with KAM, that FDA cannot convert its decission.
Geeta Pamidimukkala from FDA had this talk at RAPS 2014 about it. I could not find it in her slides, so maybe it was a question after her talk. If you have access to the web content of RAPS 2014 there is a video from this session. You might find it there.

Best,
Dirk


-------------------------------------------
Dirk Steinhoff
Regulatory Affairs Manage
Volketswil
Switzerland
-------------------------------------------


Original Message:
Sent: 10-20-2014 08:12
From: Kerri-Anne Mallet
Subject: FDA policy on RTA (Refuse to Accept)

I do not believe this is accurate. I recently attended a seminar at RAPS about the 510(k) process and the speaker from FDA (name escapes me at the moment) said that if the FDA accepts a Special 510(k) as part of the RTA, they cannot officially convert it later. They may decide to ask for more information during the substantive review but FDA would have to "eat the extra time". Thus theY still only have 30 days instead of 90 days to make their decision, but you will likely have more clock stops.

KAM


-------------------------------------------
Kerri-Anne Mallet
K-Med Regulatory Services
Attleboro MA
United States
-------------------------------------------

Kerri-Anne:

Believe me; they can and do convert Special 510(k)s to Traditional.  Been there, suffered that.

The RTA is intended to be only an administrative review.  If, in the course of their Substantive Review, they have questions that require test data, then they MUST convert to a Traditional 510(k). 

Our job, as regulatory affairs experts, is to provide a Special 510k that is so chocked full of outstanding descriptions and information that they don't have to ask for the formal report.

-------------------------------------------
Craig Coombs RAC
President
Coombs Medical Device Consulting
Alameda CA
United States
-------------------------------------------


Original Message:
Sent: 10-20-2014 08:12
From: Kerri-Anne Mallet
Subject: FDA policy on RTA (Refuse to Accept)

I do not believe this is accurate. I recently attended a seminar at RAPS about the 510(k) process and the speaker from FDA (name escapes me at the moment) said that if the FDA accepts a Special 510(k) as part of the RTA, they cannot officially convert it later. They may decide to ask for more information during the substantive review but FDA would have to "eat the extra time". Thus theY still only have 30 days instead of 90 days to make their decision, but you will likely have more clock stops.

KAM


-------------------------------------------
Kerri-Anne Mallet
K-Med Regulatory Services
Attleboro MA
United States
-------------------------------------------

I completely agree with you Craig. Passing through the administrative review of the RTA process in the first 15 days would have no bearing on whether or not FDA could (or will) convert a Special 510(k) to a Traditional 510(k). By definition, the RTA review period is not supposed to be a substantive review (in practice, it does at times delve into the substance of the submission, however).

So, given that the assessment of the technical "substance" of the submission does not commence until after the administrative review period, then within RTA review, the reviewer would not yet have been able to determine whether the summary of Design Control activities in the Special 510(k) is adequate to support a determination of SE...or whether the actual test data is required, which (as Craig mentioned), would require the submission to be converted into a Traditional 510(k).

-------------------------------------------
Karl Nittinger
-------------------------------------------


Original Message:
Sent: 10-21-2014 09:29
From: Craig Coombs
Subject: FDA policy on RTA (Refuse to Accept)

Kerri-Anne:

Believe me; they can and do convert Special 510(k)s to Traditional.  Been there, suffered that.

The RTA is intended to be only an administrative review.  If, in the course of their Substantive Review, they have questions that require test data, then they MUST convert to a Traditional 510(k). 

Our job, as regulatory affairs experts, is to provide a Special 510k that is so chocked full of outstanding descriptions and information that they don't have to ask for the formal report.

-------------------------------------------
Craig Coombs RAC
President
Coombs Medical Device Consulting
Alameda CA
United States
-------------------------------------------


Original Message:
Sent: 10-20-2014 08:12
From: Kerri-Anne Mallet
Subject: FDA policy on RTA (Refuse to Accept)

I do not believe this is accurate. I recently attended a seminar at RAPS about the 510(k) process and the speaker from FDA (name escapes me at the moment) said that if the FDA accepts a Special 510(k) as part of the RTA, they cannot officially convert it later. They may decide to ask for more information during the substantive review but FDA would have to "eat the extra time". Thus theY still only have 30 days instead of 90 days to make their decision, but you will likely have more clock stops.

KAM


-------------------------------------------
Kerri-Anne Mallet
K-Med Regulatory Services
Attleboro MA
United States
-------------------------------------------

KAM, et al,

This is reproduced from the FDA's web-site, I am confused now. 

Dar


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


Original Message:
Sent: 10-20-2014 08:12
From: Kerri-Anne Mallet
Subject: FDA policy on RTA (Refuse to Accept)

I do not believe this is accurate. I recently attended a seminar at RAPS about the 510(k) process and the speaker from FDA (name escapes me at the moment) said that if the FDA accepts a Special 510(k) as part of the RTA, they cannot officially convert it later. They may decide to ask for more information during the substantive review but FDA would have to "eat the extra time". Thus theY still only have 30 days instead of 90 days to make their decision, but you will likely have more clock stops.

KAM


-------------------------------------------
Kerri-Anne Mallet
K-Med Regulatory Services
Attleboro MA
United States
-------------------------------------------

Agree with David,

Dar

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


Original Message:
Sent: 10-19-2014 14:33
From: David Lim
Subject: FDA policy on RTA (Refuse to Accept)

"Yes" was meant to mean that FDA can convert from a special to a traditional 510(k) before or after the RTA admin review.  


Original Message:
Sent: 10-19-2014 14:29
From: David Lim
Subject: FDA policy on RTA (Refuse to Accept)

Yes.

Please refer to http://wp.me/P33LGu-3o3 

"If the file is converted from a special to a traditional after the 15 calendar day acceptance review period, any missing information that would have resulted in RTA designation should be obtained during the substantive review."

It should be construed as if the FDA is NOT bound as reflected in the said guidance.  

____________________________________________________________
Dr. David Lim, Ph.D., RAC, ASQ-CQA 

President and CEO | REGULATORY DOCTOR
Phone (Toll-Free): 1-(800) 321-8567

Direct-dial: (540) 763-3333

Fax: (866) 591-5671

E-mail:  David@RegulatoryDoctor.com

- About What I Do at https://www.youtube.com/watch?v=W_HOyfNaQVE#t=90

- About Regulatory Doctor at https://www.youtube.com/watch?v=QegpaHXlfqQ or https://www.youtube.com/watch?v=tHlOzqQXNg8

- You may book an appointment at http://www.vcita.com/v/regulatorydr

- Providing global and FDA compliance seminars at http://www.globalcomplianceseminar.com

- QR Code

"Knowledge is power only when it is practiced and put into action." - Regulatory Doctor

Original Message:
Sent: 10-19-2014 01:47
From: Asher Kassel
Subject: FDA policy on RTA (Refuse to Accept)

If the FDA performs an administrative review of a Special 510(k) as part of the RTA process, and decides that the submission fulfills the requirements/criteria of a Special 510(k), can it happen that during the course of the substantive review, the FDA may decide that the submission should be a Traditional? In other words, is the FDA "bound" by its finding at the stage of the RTA administrative review?   

-------------------------------------------
Asher Kassel
Lifewatch Technologies Ltd.
Rehovot
Israel
-------------------------------------------

As with others who have responded, it has been my experience that the FDA can, and will, convert a Special 510(k) to a Traditional 510(k) during the substantive review even though it made it through the RTA review as a Special.  As others have pointed out, the RTA review is solely administrative and verifies that the required standard content is present - a determination as to whether that content is sufficient to support an SE determination does not occur during the RTA review.

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


Original Message:
Sent: 10-19-2014 01:47
From: Asher Kassel
Subject: FDA policy on RTA (Refuse to Accept)

If the FDA performs an administrative review of a Special 510(k) as part of the RTA process, and decides that the submission fulfills the requirements/criteria of a Special 510(k), can it happen that during the course of the substantive review, the FDA may decide that the submission should be a Traditional? In other words, is the FDA "bound" by its finding at the stage of the RTA administrative review?   

-------------------------------------------
Asher Kassel
Lifewatch Technologies Ltd.
Rehovot
Israel
-------------------------------------------

The questions at the beginning of the checklist are supposed to allow FDA to determine if the submission meets the criteria for a Special. That being the case I agree with David that I would rather have a submission reclassified as traditional than NSE'd as a special

-------------------------------------------
Anthony Piotrkowski
Regulatory Manager
STERIS
Mentor OH
United States
-------------------------------------------


Original Message:
Sent: 10-22-2014 14:10
From: Laurie Cartwright
Subject: FDA policy on RTA (Refuse to Accept)

As with others who have responded, it has been my experience that the FDA can, and will, convert a Special 510(k) to a Traditional 510(k) during the substantive review even though it made it through the RTA review as a Special.  As others have pointed out, the RTA review is solely administrative and verifies that the required standard content is present - a determination as to whether that content is sufficient to support an SE determination does not occur during the RTA review.

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


Original Message:
Sent: 10-19-2014 01:47
From: Asher Kassel
Subject: FDA policy on RTA (Refuse to Accept)

If the FDA performs an administrative review of a Special 510(k) as part of the RTA process, and decides that the submission fulfills the requirements/criteria of a Special 510(k), can it happen that during the course of the substantive review, the FDA may decide that the submission should be a Traditional? In other words, is the FDA "bound" by its finding at the stage of the RTA administrative review?   

-------------------------------------------
Asher Kassel
Lifewatch Technologies Ltd.
Rehovot
Israel
-------------------------------------------

Hi All, It seems I may have stirred the pot a bit. Since I have not had the unfortunate experience of having a Special 510(k) be converted -either during the RTA process or substantive review (knock on wood), I cannot speak from practical experience. My comment was purely based on the talk given at RAPS this year, which seems consistent with the FDA guidance on RTA policy that was issued in 2012 ( http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm315014.pdf, bottom of page 13). However, I defer to the others who have had (or are familiar with) recent experience having a Special be converted to a Traditional during the substantive review process. KAM ------------------------------------------- Kerri-Anne Mallet K-Med Regulatory Services Attleboro MA United States -------------------------------------------
Original Message: Sent: 10-23-2014 16:45 From: Anthony Piotrkowski Subject: FDA policy on RTA (Refuse to Accept) The questions at the beginning of the checklist are supposed to allow FDA to determine if the submission meets the criteria for a Special. That being the case I agree with David that I would rather have a submission reclassified as traditional than NSE'd as a special ------------------------------------------- Anthony Piotrkowski Regulatory Manager STERIS Mentor OH United States -------------------------------------------
Original Message: Sent: 10-22-2014 14:10 From: Laurie Cartwright Subject: FDA policy on RTA (Refuse to Accept) As with others who have responded, it has been my experience that the FDA can, and will, convert a Special 510(k) to a Traditional 510(k) during the substantive review even though it made it through the RTA review as a Special. As others have pointed out, the RTA review is solely administrative and verifies that the required standard content is present - a determination as to whether that content is sufficient to support an SE determination does not occur during the RTA review. ------------------------------------------- Laurie Cartwright Senior Manager II, Regulatory Affairs Smith & Nephew (formerly ArthroCare Corporation) Irvine CA United States -------------------------------------------
Original Message: Sent: 10-19-2014 01:47 From: Asher Kassel Subject: FDA policy on RTA (Refuse to Accept) If the FDA performs an administrative review of a Special 510(k) as part of the RTA process, and decides that the submission fulfills the requirements/criteria of a Special 510(k), can it happen that during the course of the substantive review, the FDA may decide that the submission should be a Traditional? In other words, is the FDA "bound" by its finding at the stage of the RTA administrative review? ------------------------------------------- Asher Kassel Lifewatch Technologies Ltd. Rehovot Israel -------------------------------------------

The guidance clearly states "If the file is converted from a special to a traditional after the 15 calendar day acceptance review period, any missing information that would have resulted in RTA designation should be obtained during the substantive review."

I think the provide an clear indication that their is the possibility that the submission could be accepted as a Special and later converted to a traditional during the substantive review.

Lee

-------------------------------------------
Lee Leichter RAC
President
P/L Biomedical
Fort Myers FL
United States
-------------------------------------------


Original Message:
Sent: 10-25-2014 14:51
From: Kerri-Anne Mallet
Subject: FDA policy on RTA (Refuse to Accept)

Hi All,

It seems I may have stirred the pot a bit. Since I have not had the unfortunate experience of having a Special 510(k) be converted -either during the RTA process or substantive review (knock on wood), I cannot speak from practical experience. My comment was purely based on the talk given at RAPS this year, which seems consistent with the FDA guidance on RTA policy that was issued in 2012 (
http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm315014.pdf, bottom of page 13).
However, I defer to the others who have had (or are familiar with) recent experience having a Special be converted to a Traditional during the substantive review process.

KAM

-------------------------------------------
Kerri-Anne Mallet
K-Med Regulatory Services
Attleboro MA
United States
-------------------------------------------