The following are excerpts from Thor Rollins’ article, How the New FDA Biocompatibility Testing Guidance Could Affect You, originally published in the May 2014 edition of MDDI Magazine.
In April 2013, FDA released draft guidance for industry and FDA administration staff titled “Use of International Standard ISO 10993, ‘Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.’” Meant to replace FDA’s 1995 G95 document, the new draft guidance document is the most expansive presentation of testing standards affecting the medical device industry in more than 18 years.
In the past, performing medical device testing was like checking off boxes. Neither the device type, type and duration of contact, nor materials mattered. While G95 was used as a kind of checklist, the new guidance teaches testing professionals how to change materials or how to view testing in a more scientific way. It puts more emphasis on scientific analysis, thus compelling professionals to have more knowledge and background about the tests they perform. In addition, it contains good ideas on how to justify biocompatibility testing—specifically animal testing—and presents ways for limiting the use of such tests for certain devices.
While many of the ideas contained in the new guidance document have appeared in FDA response letters over the past two years and more, it also incorporates changes that are new to the medical device industry.
- Test for All Types of Exposures: The first such change is that devices subjected to multiple types of exposures should be tested for all of them.
- Conduct Extract Tests on All Components Separately: Another change in the new draft guidance document stipulates that if a device includes components that contact the body for different lengths of time… extract tests should be conducted on the components separately.
- Use the Mouse Lymphoma Test for Genotoxicity: The new guidance document has settled on the mouse lymphoma test because it detects the broadest set of genotoxic mechanisms associated with carcinogenic activity.
- Devise a Meaningful Test Outline: The new draft document puts greater emphasis than G95 did on the importance of knowing the scientific rationale behind the tests that are performed and devising a meaningful test outline for the device.
- A Reference for Manufacturers: By codifying these standards in a single document, FDA has enabled medical device manufacturers and testing facilities to reference them in order to perform such tasks as setting up a test design or evaluating the impact of a failure.
For a more detailed analysis of the new draft guidance and how it may affect you, read the extended version of Mr. Rollins’ MDDI Magazine article on MDDI.com.