The current edicts at the FDA/ CDRH (Center for Devices) Office of Device Evaluation (ODE) is that device approvals must become more strenuous. The original CDRH is created by an act from Congress to regulate the COMMERCE of medical device. That has not been changed. The CDRH has taken it upon themselves to do this "strengthening" for Class II medical devices- not Congress.


The "strengthening" objectives are heralded as making the devices "safer". But the reality is other approvals such as UL and other safety standards do that. The FDA / CDRH is focusing more on restricting "claims" of how the device is applied in medicine than the safety.


Consider that "depression" prescription drugs are used off label with frightening regularity. Are people still depressed? Why are drug approvals more tolerant than device approvals with regard to the claims that are stated?

It's okay to be alarmed about your medical device approval

As an inventor, you may have devoted much of your life creating a medical device and it may be the center piece of your medical practice. We do not take your confidence in us -lightly! Trust us to be diligent -so your application will have a gentle regulatory future. We create a regulatory plan and strategy that serves your product risk and performance. We balance creativity with aggressive performance - but plan with absolute caution.