FDA, new technology approval and the Ossification Tango (US)

When it comes to new technologies–and drugs for that matter–the worst thing that can happen to your invention is to receive a letter from FDA that you have been classified into Class III. Based on regulations passed by Congress in 1976, there are three FDA classes primarily based on device risk. Exception: Class III. Anything not ‘substantially equivalent’ to an existing device is automatically put into Class III, regardless of risk level. Author and health tech legal advocate Bradley Merrill Thompson of Epstein Becker Green takes a comprehensive review at this flawed and outdated system that puts groundbreaking health tech at an extreme disadvantage in his latest article on regulation in Mobihealthnews.US companies in our field spend a great deal of time and treasure avoiding it, through reclassification petitions and occasionally a ‘de novo submission’ creating a new classification. What says it all about FDA is that when Mr Thompson proposed to FDA officials that they Party Like It’s 1976 and update their classification systems to make it easier for low risk, already regulated software, it was much like one of those ‘you want it when?’ cartoons. The theme of the Ossification Tango is money and ‘institutional reluctance’; companies with innovative and especially pioneering software and devices cannot even be heard in Foggy Bottom. The last part of the article discusses a master plan for the classification of health information technology (HIT) type medical devices. It’s little wonder that a fair amount of innovation has left American shores, only to dare back once there’s a track record ex US.