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FDA Biocompatibility Tips: Multiple Absorbability, Allergenicity Testing Methods To Choose From

An FDA device reviewer and an agency toxicologist talk to The Gray Sheet about key industry considerations for biocompatibility testing, emphasizing a growing focus on testing absorbable implants and testing for allergens in devices.

Biocompatibility testing of device materials is a challenge faced by many device manufacturers, and it is a key element of many 510(k)s and PMAs coming before FDA.

In particular, growing interest by industry in absorbable devices has heightened the agency's attention to testing that ensures materials assimilating into the body from devices are safe for the intended...

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