Do Device Verification Bench Tests need to be GLP?

When one submits an IDE application, the sponsor must state that " All of the above mentioned laboratory evaluations were conducted in compliance with the provisions of Good Laboratory Practice (GLP) Regulations, Title 21 CFR Part 58." Are device verification bench tests considered laboratory evaluations and does this apply to medical device verification bench tests or only to animal testing?

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Stijloor.

dblnkl said:

When one submits an IDE application, the sponsor must state that " All of the above mentioned laboratory evaluations were conducted in compliance with the provisions of Good Laboratory Practice (GLP) Regulations, Title 21 CFR Part 58." Are device verification bench tests considered laboratory evaluations and does this apply to medical device verification bench tests or only to animal testing?

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I don't know a direct answer to the question...I'd think that the answer might be dependent on what the medical device is, and what testing is being done. But more generally, 21CFR 58.1 "Scope" clearly states applicability to "nonclinical laboratory studies" of "medical devices". If the location where the bench testing is done is in any way characterized or qualified as a lab, or under rules that apply to labs, I'd think that you'd be close enough to whatever boundary might exist that compliance would be appropriate.

IND or IDE?
Investigational New Drug (IND) Application

What do you mean by IDE?
IDE Approval Process

Device Advice: Investigational Device Exemption (IDE)

I asked Division of Small Manufacturers, International and Consumer Assistance (DSMICA) at the FDA and they replied that, yes, bench verification studies for submission are required to follow GLP (21 CFR 58).

I know this thread is old...but I was interested to see that FDA told you this. The scope of the GLP regulations (21 CFR 58) is as follows:

58.1(a) This part prescribes good laboratory practices for conducting nonclinical laboratory studies that support or are intended to support applications for research or marketing permits for products regulated by the Food and Drug Administration, including food and color additives, animal food additives, human and animal drugs, medical devices for human use, biological products, and electronic products. Compliance with this part is intended to assure the quality and integrity of the safety data filed pursuant to sections 406, 408, 409, 502, 503, 505, 506, 510, 512-516, 518-520, 721, and 801 of the Federal Food, Drug, and Cosmetic Act and sections 351 and 354-360F of the Public Health Service Act.

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And then a bit further down we have (emphasis added):

58.3(d)Nonclinical laboratory study means in vivo or in vitro experiments in which test articles are studied prospectively in test systems under laboratory conditions to determine their safety. The term does not include studies utilizing human subjects or clinical studies or field trials in animals. The term does not include basic exploratory studies carried out to determine whether a test article has any potential utility or to determine physical or chemical characteristics of a test article.

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The "physical or chemical characteristics" part seems clear to me that the type of bench testing you're describing would be excluded. I'd be interested to hear if anyone else has any opinions or experience with this!

Jen

While there is no explicit requirement that verification studies follow GLP, it is not a bad idea. It is true that, when you submit an IDE application, you need to make that statement or at least address the issue. If your studies are not according to GLP (bench and/or animal), you should present a justification for why not (high costs do count) and what you did to compensate for no GLP (i.e., why what you did was just as good as GLP, without the added overhead and expense). Justifications could include carefully designed protocols and adherence to rigid data collection and analysis techniques. Especially, in running animal studies, GLP standards increase the costs to the sponsor significantly (+30%-50%). My practice has been to design non-GLP animal studies like I would under GCP, with full-up SOPs, thorough protocols, CRFs, entry of results into a verified clinical database, full-up stats, and careful analysis and write-up. That approach has never been a problem for me. But no guarantees! Many people I know just do not want to take the risk and so do GLP animal studies. Others run early animal studies without GLP, with the final one on GLP. Still others make the statement that they are GLP even though their (especially bench) studies are non-GLP. That seems to be a bigger risk to me. But I do not know of any one getting caught on this. Maybe others do?

Are you talking about bench tests that are also animal studies? I was taking "verification bench testing" for a medical device to be tests like tensile testing, corrosion resistance, MRI compatibility...etc. I think it would be hard to follow the GLP regs exactly for such studies even if you wanted to, because so much of 21 CFR 58 deals specifically with provisions for working with animals. Maybe I was misunderstanding the original question?