Regulatory Strategy for Medical Devices in the US

Duration of contact Invasiveness Mode of action Impact on body 

Long term Surgically invasive Active Systemic 

The regulation of medical devices in the U S was introduced with the Medical Device Amendments to FDC Act in 1976. These are supported by regulations published in 21 CFR parts 800-899. The Center for Devices and Radiological Health (CDRH) is the responsible section within the FDA for regulation of devices. 

---

Regulatory Strategy for Medical Devices in the US 177 NON INVASIVE DEVICES... 

---