Regulatory Requirement for Extractable and Leachables from Medical Devices
Extractables and leachable testing is required by the CDRH in the FDA for many medical devices. Experimental design for evaluation of extractable and leachables from medical devices can be done based on the most likely route for a leachable to enter the body. One route of entry is for leachables from a medical device to enter a drug product that carries the leachable into a patient. Examples of medical devices were this is the leachable route of entry include infusion pumps, syringes, and syringe filters. For leachables in this category, both the toxicity of the leachable and the potential impact of the leachable on the drug product need to be considered. The second route of entry is direct migration of the leachable from the medical device into the patient from direct tissue contact. Examples of medical devices where this is the leachable route of entry include dental implants, artificial joints, stents, bandages, and contact lens. For some medical devices, both routes of entry for leachables are possible. Examples of medical devices where both routes of entry are possible include drug releasing implants and catheters. If leachables from a medical device are unlikely to enter the body from one of these two routes, an evaluation of extractables and leachables is probably not necessary.
To address extractables testing for medical devices, in the FDA Modernization Act of 1997, the FDA recognized ISO 10993-12 Titled “Sample Preparation and Reference Materials”. In this document are clearly defined extraction experiments for extractable and leachable evaluations. Some of the definitions and experiments in ISO 10993-12 are similar to the definition of an extractable and the forced extraction studies described in the PQRI guidance for E&L testing of OINDP. Acceptance criteria for extractables and leachables are not defined in ISO 10993-12.
Based upon the similarities between ISO 10993-12 and the PQRI guidance for E&L testing of OINDP, Pine Lake Laboratories has developed a study design for medical devices based upon the route of entry for the leachables. This study design is available in the technical library as a white paper titled “Extractables and Leachables for Medical Devices: Meeting the 510(k) Requirements.”