| Year | Description |
|---|---|
| 1906 | FDA first regulation (no medical devices yet) |
| 1938 | FD&C Act: Limited Regulation of medical devices |
| 1961 | Over the counter drugs become regulated |
| 1962 | Regulations that request efficacy data |
| 1969 | Cooper committee formed to advise new regulation |
| 1976 | With Cooper committee input medical device amendments were added. First time to distinguish between devices and drugs. |
| 1978 | Good Manufacturing Process (GMP) regulations made. Allows for facility inspection & can prohibit shipment |
| 1990 | Safe Medical Devices Act (SMDA) Add pre-production design validation to GMP |
| 1996 | Monitor Device Reporting (MDR) Report device-related deaths to the FDA & manufacturer (by practitioners) Report serious illness Submit semi annual summary |
It seems as if the FDA was a lot less tough for a long time. I mean basically it was not a force to be reckoned with till the late 70s. Since then regulations are often updated. It would be interesting to see their funding over the same time period.