Extent of Recognition of ISO 10993-1

R

regfocus

#1
May I ask a question about the ISO 10993-1:2003, Biological evaluation of medical devices -- Part 1: Evaluation and testing. (Biocompatibility) please? When I go to FDA recognized standard database at

http://www.accessdata.fda.gov/scrIpt...ation_no=26534
It says:
"Extent of Recognition:
Complete standard and any annexes, except Tables 1 and 2"

My question is

1) Does that mean Table 1 and 2 is not acceptable by FDA?
2) If Table 1 and 2 is not acceptable by FDA, how do we know which evaluation tests, such as ISO 10993-5, 10, etc., we should do?
 
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Kevin Mader

One of THE Original Covers!
Staff member
Admin
#3
regfocus,

In short, FDA sometimes has a hard time formally recognizing the ISO standards (not created by them I suppose). That being said, they accept test data/summaries based on the guidance for new product submissions and are taking steps to better harmonize globally.

I don't have a copy of the ISO standard with me, but it may be that they haven't been able to corroborate/align with some of the specifics in the tables. My advice is to contact FDA at the number provided/contact provided at the link above to iron out any questions or concerns.

My experience with FDA reviewers is that they are more than willing to give you direction. Setting up a preliminary discussion to iron out the wrinkles is also advisable and will save headaches down the road and speed up approval processes. 15 minutes spent up front will save you tons of time, money and effort.

Regards,

Kevin
 

Michael Malis

Quite Involved in Discussions
#4
regfocus,

In short, FDA sometimes has a hard time formally recognizing the ISO standards (not created by them I suppose). That being said, they accept test data/summaries based on the guidance for new product submissions and are taking steps to better harmonize globally.

I don't have a copy of the ISO standard with me, but it may be that they haven't been able to corroborate/align with some of the specifics in the tables. My advice is to contact FDA at the number provided/contact provided at the link above to iron out any questions or concerns.

My experience with FDA reviewers is that they are more than willing to give you direction. Setting up a preliminary discussion to iron out the wrinkles is also advisable and will save headaches down the road and speed up approval processes. 15 minutes spent up front will save you tons of time, money and effort.

Regards,

Kevin
Hi Kev,

You are right on the money, as usual. Discussion with the FDA rep. will save a lot of efforts. By the way, ISO 10993 is one of the few standards that FDA is formally recognized...
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#5
Hello Mike,

The time saved with a pre-sell and with FDA guidance was very valuable. It is much easier preparing a submission when the reader has given you their input. It is very easy to get caught up on documenting all the technical jargon but more important that it doesn't end up clouding the message. Their time and your time are valuable, so tailoring submission material helps out everyone.

Good to see you at the Cove after a spell away (for us both?).

Kev
 

Qara123

Involved In Discussions
#6
May I ask a question about the ISO 10993-1:2003, Biological evaluation of medical devices -- Part 1: Evaluation and testing. (Biocompatibility) please? When I go to FDA recognized standard database at

http: // www. accessdata.fda.gov/scrIpt...ation_no=26534 - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS
It says:
"Extent of Recognition:
Complete standard and any annexes, except Tables 1 and 2"

My question is

1) Does that mean Table 1 and 2 is not acceptable by FDA?
2) If Table 1 and 2 is not acceptable by FDA, how do we know which evaluation tests, such as ISO 10993-5, 10, etc., we should do?
FDA modified Tables 1 & 2, see the Blue Book Memo G95-1. Specifically, " [FONT=&quot]FDA has made several modifications to the testing required by ISO 10993-Part 1. These modifications are required for the category of surface devices permanently contacting mucosal membranes (e.g., IUDs). The ISO standard would not require acute, sub-chronic, chronic toxicity and implantation tests. Also, for externally communicating devices, tissue/bone/dentin with prolonged and permanent contact (e.g., dental cements, filling materials etc.), the ISO standard does not require irritation, systemic toxicity, acute, sub-chronic and chronic toxicity tests. Therefore, FDA has included these types of tests in the matrix"

Blue Book Memo G95-1 - http :// www .fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/ucm080735.htm - OBSOLETE BROKEN 404 LINK(s) UNLINKED - PLEASE HELP - REPORT POSTS WITH BROKEN LINKS

Q
 
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