Genotoxicity reviews
Because most products were developed absent of genotoxic risk, genotoxicity reviews of hundreds to thousands of medical device and drug submissions showed mostly negligible human safety concerns. Rare exceptions of notable human hazards included a known mutagen with direct exposure to human germ cells, encountered early on. This was not recognized as a hazard despite my efforts. Later on, my opinion might have had more impact. A different agent, methylene blue, was reviewed as a drug with multiple indications and was also a component of medical devices. This was the most interesting agent I ever encountered, considered non-hazardous by physicians because of its continuous use for by Larry Loeb and others and activated by enzymes or light. It has been cited as the world’s oldest drug and seems to be treated as GRAS (generally recognized as safe), although that attribution is usually limited to food-based agents. You can buy it at Walmart for your fish tank. I made a presentation illustrating the dual non-overlapping pathways of methylene blue as a therapeutic and as a classical mutagen. And never the twain have met.