December 2007 Summary
December 2007 Summary Regulation by Tim Samsel
Tim Samsel gave a talk titled “Device Regulation - Past, Present and Future”. In the US, we often think regulation means the FDA, but in truth the FDA is only one of many regulatory agencies that affect our lives. Others include the SEC, OSHA, and the FCC. The FDA recently celebrated its 100th year. It began in 1906 in reaction to Upton Sinclair’s book “The Jungle” that told about the horrors of the meat processing industry around the turn of the 20th century. In 1938 and again in 1962 the FDA’s oversight over drugs increased, and finally its influence over medical devices began in earnest in 1976. All this is in response to the expectation in modern societies that it is one of the government’s jobs to protect its citizens from harm.
One of Tim’s key points was that we should not forget the FDA is a political organization, not a scientific one. That realization explains a lot according to Tim. The rules under which the FDA operates is part 21 of the Federal Code of Regulations (CFR). There are 10 sub parts for devices and more when one considers combination products.
The FDA interacts with device manufacturers via many vehicles that include submissions, audits and inspections. The PMA and 510K are the best known submission types, but there are also others for special purposes. Sometimes there is debate over how the FDA does its job. This debate is really over how they interpret the words in the CFR. The FDA is also sometimes involved in controversies over other things like user fees and review time lines.
Outside the US the picture is quite different. In Europe the regulatory process works through what is called notified bodies – companies charged with approving medical devices for sale. These notified bodies regulate based on conformance to standards, and the standards are provided via organizations such as ISO.
Both the FDA and notified bodies have many tools in their tool box to enforce compliance. These include the threat of criminal penalties. The FDA’s existence greatly shapes the world medical device companies live in. The FDA helps ensure the public’s confidence in our health care system, but it also does things like raise the barriers for competition.
Tim ended his talk by discussing four trends in the regulatory world.
- Increasing regulator to regulator communication around the world
- Increasing global harmonization
- Increasing focus on supplier quality and post market surveillance
- Increasing regulation in emerging markets like China, India and Korea