How the New FDA Guidance on Biocompatibility Affects Medical Device Manufacturers
Audrey Turley and Thor Rollins – Posted in Testing Services by MDDI Staff on December 20, 2016
In June 1906, President Theodore Roosevelt signed into law the Food and Drug Act, which addressed “adulterated” products. Adulterated includes the addition of fillers of reduced “quality or strength;” coloring to conceal “damage or inferiority;” formulation with additives “injurious to health;” or the use of “filthy, decomposed, or putrid” substances in a product. It took until 1995 for FDA to release an official guidance specific to medical device regulation.
This document, known as the “blue book,” was the basis of biocompatibility regulation for decades. FDA published a draft guidance document on the “Use of International Standard ISO 10993-1 ‘Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process’” in April 2013, and this draft marked the first updated direction regarding biocompatibility from FDA. A final version was issued in June of this year, which was officially adopted as the replacement for the G95 Bluebook memorandum on September 14, 2016.
During the three years that the document circulated as a draft, it doubled in length providing great insight into FDA’s regulatory expectations and the agency’s interpretation of the ISO 10993-1 guidelines in general. FDA guidance document on the use of ISO 10993-1 outlines the testing approach necessary to bring a medical device to market. Medical device manufacturers need to consider FDA’s interpretation of the ISO 10993-1 standard.
This guidance document can be divided into three areas: current thinking, new trends, and justification information. Current thinking references statements or thought processes that are recent trends from FDA as seen in feedback from medical device submissions. New themes are areas of updated insight or clarification of approaches to be taken. Justification information provides alternatives to the standard in vitro/in vivo biocompatibility tests in addressing specific biological endpoints.