The FDA is revamping their medical device clearance process after a week of none-too-flattering press coverage related to med device issues. The current process for med device approval can be accelerated if companies demonstrate their product is substantially equivalent to already approved products. Trouble is that technology evolves every once in a while (in infographic form here), so the new process puts a ten-year limit on using a reference product. The agency is pursuing these changes after stories like this which allege that medical devices have caused 80,000+ deaths since 2008. Other stories included ‘export-only’ devices made in the US without FDA approval causing injuries abroad, and Health Canada changing their clearance process after similar criticisms. Looks like a change is gonna come. Here are 2018’s 10 most innovative medical devices.
Homeopathy is based on the idea that you can treat sick people with diluted versions of substances that would cause the sick person’s symptoms in a healthy person. So, we guess it’s something like building up an immunity to iocane powder, except without any clinical evidence. In the US, homeopathy is a multibillion dollar industry and the FDA has taken notice. They’ve kind of let homeopathic solutions do their own thing for years now but homeopathic teething products, recently implicated in 400 adverse events, including the deaths of 10 children, have the FDA a bit more ready to take action. The agency is getting serious about getting the most dangerous homeopathic products off the market, which will hopefully help to avert these tragedies in the future.