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| FDA issued a new draft guidance in 2013 on the biological evaluation of medical devices. |
by Cheryl Wagoner
Principal Consultant/Owner
Wagoner Consulting LLC
As part of FDA’s efforts to harmonize their requirements with those around the world, it has issued a number of guidance documents to help explain the agency’s position, especially in cases where FDA has some variance with a given international standard. The current FDA guidance regarding biological evaluation of medical devices, Blue Book Memo #G95-1, was issued July 1, 1995 and replaced the FDA Tripartite Biocompatibility Guidance #G87-1 (April 24, 1987). On April 23, 2013, FDA issued a new draft guidance entitled “Use of the International Standard ISO-10993 BiologicalEvaluation of Medical Devices Part 1: Evaluation and Testing”. This guidance has much in common with the current Blue Book Memo, but expands the details in a number of areas especially regarding the test matrix and the level of detail regarding each test.
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