Julie,
With the notion that a device is subject to few to many biocomp studies.
So timelines from A to B can quite vary from 2 weeks to several months and ever over a year.
The risk assessment itself can be easily done in a week or two.
As for a device dev project planning, you would want to allow some generous timelines.
So assuming your device is subject to three biocomp studies (cytox, genotoxicity and hemolysis) under GLP.
For cyto,
- agarose overlay takes about 2 weeks.
- MEM elution, it takes about 2 weeks too.
- For cyto, if you choose/have to do an MTT assay, it takes about 3 weeks.
For geno,
- Ames study, it takes about 4 weeks
- Bacterial muta, it takes about 4 weeks.
.
For hemolysis,
- a direct contact method takes about 3 weeks.
- an extract method takes about 3 weeks.
For these three, from A to B, I would say "6-10 weeks" unless you outsource all studies performed concurrently.
Based on test reports even if they are not finalized, I would add 2 additional weeks for risk assessment.
Thus, 8-12 weeks of time may be needed.
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http://www.regulatorydoctor.com
Riner VA
United States
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Original Message:
Sent: 04-19-2014 13:32
From: Julie Omohundro
Subject: Risk-Based Biocompatiblity Assessment Timeframes?
I'm afraid I didn't ask my question very clearly, for which I apologize. For people with experience with ISO 10993 risk-based biocompatiblity assessment with new devices, I would like to know about how much PROJECT time it takes to get from:
Time Point A - You have manufactured devices ready for testing
to:
Time Point B - The tox risk assessment of the results of the chemical characterization/quantification of degradation products has been completed.
I am asking for the purposes of project planning. I came to this forum because a regulatory professionals is often a member of a new product development team, one who tends to pay close attention to the biocompatibility validation. The biocompatibility and toxicology experts are typically external to the product development team and are often external to the company. Therefore, regulatory professionals are likely to be in a position to know how long it took a project to get from A to B, where bio/tox experts are not,
As an example, I was planning to give my tox assessment consultant a week to turn around the risk assessment, but that's not project time, that just the consultant's turnaround time. Project time is something quite different. If you have been part of a project team through the design V&V phase, you know what I mean. And if you have, then I would be very grateful to know of your experience with this part of it.
Thanks.
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Julie Omohundro RAC
Durham NC
United States
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Julie Omohundro RAC
Durham NC
United States
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Original Message:
Sent: 04-17-2014 12:09
From: Julie Omohundro
Subject: Risk-Based Biocompatiblity Assessment Timeframes?
If you have experience with ISO 10993 risk-based biocompatiblity assessment with new devices, I would like to know about how long it takes to get from the date on which you devices available for testing to the date you have completed the risk assessment that is based on the results of chemical characterization and quantification of degradation products.
Thanks,
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Julie Omohundro RAC
Durham NC
United States
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