Regulatory Open Forum

Did you miss the ASCA Pilot program update webinar today.  Was a really good webinar it covered a lot of good topic including a lot of info on the Biocompatibility testing, what test labs need to do and of course what manufacturers need to do.  It also got into the details about the Declarations of Conformity & the Test LAb Summary reports and that the manufacturer is responsible for the details in that summary report but the manufacturer can change the details in that report.  You will need to work with the lab upfront and throughout the project more than maybe you have done in the past and the FDA is hoping you do that.  One of the slides even said that.  You can get the slide deck and they will post the final presentation including the Q&A session (hopefully including the Q&A typed up Q&A items in a couple of days.  

Also, you can look up a definition of the ASCA program in the Regipedia

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Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
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Thanks for this Leo, it was quite late my time so was not able to listen in.  This is a great step in the right direction and hopefully other regulatory agencies around the world will implement similar programmes to utilise work other groups are doing in standardisation.

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Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE
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Original Message:
Sent: 21-May-2021 02:31
From: Leonard Eisner
Subject: FDA's ASCA Pilot Program Update Webinar - 20 May 2021

Did you miss the ASCA Pilot program update webinar today.  Was a really good webinar it covered a lot of good topic including a lot of info on the Biocompatibility testing, what test labs need to do and of course what manufacturers need to do.  It also got into the details about the Declarations of Conformity & the Test LAb Summary reports and that the manufacturer is responsible for the details in that summary report but the manufacturer can change the details in that report.  You will need to work with the lab upfront and throughout the project more than maybe you have done in the past and the FDA is hoping you do that.  One of the slides even said that.  You can get the slide deck and they will post the final presentation including the Q&A session (hopefully including the Q&A typed up Q&A items in a couple of days.

Also, you can look up a definition of the ASCA program in the Regipedia

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Glad you agree Richard.  The more submitters know about the program and use it the more benefit they will get out of it.  I have talked with several of the 60601-1 approved test labs involved in the ASCA program and know that they want this program to be successful they have put a lot of effort into being accepted into the program. I was involved in the original expert panel (I was on it) and I have worked with the FDA on this pilot program and there is hope this Pilot program will succeed and become permanent.  Hopefully will make the review process easier and less painful in the overall process for the manufacturer and better communications between the manufacturer and the test lab, the test labs and the FDA, etc.  That was one of the original goals of the program if you talk with Scott Colburn who is the Director of the Standards and Conformity Assessment Program at CDRH has told me many times.

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------

Original Message:
Sent: 23-May-2021 06:41
From: Richard Vincins
Subject: FDA's ASCA Pilot Program Update Webinar - 20 May 2021

Thanks for this Leo, it was quite late my time so was not able to listen in.  This is a great step in the right direction and hopefully other regulatory agencies around the world will implement similar programmes to utilise work other groups are doing in standardisation.

------------------------------
Richard Vincins RAC
Vice President Global Regulatory Affairs
Oriel STAT A MATRIX - ENTERPRISE

Original Message:
Sent: 21-May-2021 02:31
From: Leonard Eisner
Subject: FDA's ASCA Pilot Program Update Webinar - 20 May 2021

Did you miss the ASCA Pilot program update webinar today.  Was a really good webinar it covered a lot of good topic including a lot of info on the Biocompatibility testing, what test labs need to do and of course what manufacturers need to do.  It also got into the details about the Declarations of Conformity & the Test LAb Summary reports and that the manufacturer is responsible for the details in that summary report but the manufacturer can change the details in that report.  You will need to work with the lab upfront and throughout the project more than maybe you have done in the past and the FDA is hoping you do that.  One of the slides even said that.  You can get the slide deck and they will post the final presentation including the Q&A session (hopefully including the Q&A typed up Q&A items in a couple of days.

Also, you can look up a definition of the ASCA program in the Regipedia

------------------------------
Leonard (Leo) Eisner, P.E.
The "IEC 60601 Guy"
Principal Consultant, Eisner Safety Consultants
Phone: (503) 244-6151
Mobile: (503) 709-8328
Email: Leo@EisnerSafety.com
Website: www.EisnerSafety.com
------------------------------