biostudies-literatureAlves VMNIHNIH HHS250-259https://www.ebi.ac.uk/biostudies/studies/S-EPMC9516038biostudies-literatureUnknown189(2)In the United States, a pre-market regulatory submission for any medical device that comes into contact with either a patient or the clinical practitioner must include an adequate toxicity evaluation of chemical substances that can be released from the device during its intended use. These substances, also referred to as extractables and leachables, must be evaluated for their potential to induce sensitization/allergenicity, which traditionally has been done in animal assays such as the guinea pig maximization test (GPMT). However, advances in basic and applied science are continuously presenting opportunities to employ new approach methodologies, including computational methods which, when qualified, could replace animal testing methods to support regulatory submissions. Herein, we develoToxicological sciences : an official journal of the Society of ToxicologyPreS/MD: Predictor of Sensitization Hazard for Chemical Substances Released From Medical Devices.PMC95160381R43ES032371Muratov ENAlves VMBorba JVBBraga RCKorn DRRua DKleinstreuer NTropsha ACausey KfalsePreS/MD: Predictor of Sensitization Hazard for Chemical Substances Released From Medical Devices.In the United States, a pre-market regulatory submission for any medical device that comes into contact with either a patient or the clinical practitioner must include an adequate toxicity evaluation of chemical substances that can be released from the device during its intended use. These substances, also referred to as extractables and leachables, must be evaluated for their potential to induce sensitization/allergenicity, which traditionally has been done in animal assays such as the guinea pig maximization test (GPMT). However, advances in basic and applied science are continuously presenting opportunities to employ new approach methodologies, including computational methods which, when qualified, could replace animal testing methods to support regulatory submissions. Herein, we develo2022-01-01T00:00:00Z2022 Sep2025-04-04T20:06:50.841Z2025-04-04T20:06:50.841ZS-EPMC95160383591674010.1093/toxsci/kfac078