Here at PBL, we work with many medical device companies, and no matter whether these companies are new or established, there still seems to be common questions among them. Namely: how exactly do the GLP regulations apply to medical device studies?
This uncertainty, and, in many cases, confusion, likely stems from a lack of clarity in the GLP regulations themselves, as well as a sometimes ambiguous stance from the FDA on when GLP should be applied to medical device studies.
Based on our experience, here's a quick primer on how we find GLP can best be applied to medical device studies.
Which Medical Device Studies Should be Conducted GLP?
A quick look into the FDA GLP regulations (21 CFR part 58) reveals that GLP is only applicable when conducting nonclinical laboratory studies. This is key, because many studies don't qualify as nonclinical, and thus don't need to be conducted according to GLP.
"A nonclinical laboratory study is an in vivo or in vitro experiment in which a test article is studied prospectively in a test system under laboratory conditions to determine its safety (21 CFR 58.3(d))."
Studies that are not done for the purpose of determining the safety of a device thus do not need to be conducted according to GLP. There is occasionally a misperception that a GLP study is "better" than a non-GLP study or a study conducted according to GMP (Good Manufacturing Practices.) And this misperception can lead to study sponsors requesting GLP when it is not needed, adding unnecessary cost and length to a study.
Based the understanding that GLP is for nonclinical studies only, here are some common medical device studies and our recommendations on whether GLP is applicable.
Biocompatibility (both in-vivo and in-vitro): GLP
Validation Studies (sterilization validations, reusable device cleaning validations): either non-GLP or GMP (GLP is most likely not needed)
Exploratory Studies: GLP not needed (conduct these studies non-GLP)
Chemical Characterization Studies (such as ISO 10993-18 Chemical Characterization): GLP (most likely) not needed
Routine Lot Testing (bioburden, endotoxin, sterility): Conduct according to GMP*
*GMP is short for Good Manufacturing Practices
What Device Characterization Data is Needed for a GLP Study?
If a device study does need to be conducted GLP, then characterization data for the device (the test article) must be gathered, and this data becomes part of the GLP study.
GLP regulations require the following:
“The identity, strength, purity, and composition or other characteristics which will appropriately define the test or control article shall be determined for each batch and shall be documented. Methods of synthesis, fabrication, or derivation of the test and control articles shall be documented by the sponsor or the testing facility (21 CFR 58.105(a)).”
This language seems to be more targeted to pharmaceuticals than medical devices, so determining what data is needed for a device can be tricky. In our experience, here is what we find to be most appropriate:
Description of the device
Types of materials the device is made of (method of manufacture and name of the manufacturer of any polymers, colorants, metals, etc.)
Methods of manufacture and synthesis of the final device (i.e. injection molding) and location of manufacturing facilities.
Lot number (if applicable).
Stability data is also required, which is somewhat analogous to the device's shelf life or usable life. If this data has not been determined yet, it typically is sufficient for the manufacturer to provide a letter with an assurance that the device as tested during the relevant GLP study is within it's usable life.
For more information, and to better understand some of the FDA's stances on GLP and medical device studies, we recommend the FDA’s Draft Guidance for Industry and Food and Drug Administration Staff - The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions & Answers.
Additionally, a medical device specialist at Pacific BioLabs may be able to help assist with questions for your specific device testing project. Contact PBL to see if we may be able to help.