FDA suggested deregulating some medical devices

The FDA is taking steps to eventually deregulate

• Smart body scales
• Thermometers
• Stethoscopes
• Ophtalmic cameras
• and other Class I and II medical devices

While today’s announcement is just a proposal and requires the usual public comment period and so on, the FDA said it would not enforce 510(k) requirements for the devices it listed and it doesn’t expect companies making these devices to submit 510(k)s for them in the meantime.

The FDA is being very practical in not spending unnecessary time regulating devices with a low level of inherent danger. The EU’s regulatory agency on medical devices should take note.