Bradley Merrill Thompson, a Member of the Firm in the Health Care and Life Sciences practice, in the firm’s Washington, DC, office, was quoted in the The Wall Street Journal, in “Do the FDA’s Regulations Governing Medical Devices Need to Be Overhauled?”
Following is an excerpt:
While there are certainly some incidents of the FDA regulating devices too stringently, they are by and large the exception. You mention placebo-controlled device trials. In the example you cite, however, the FDA did not order the company to use a placebo control. That was the company’s idea. The fact that the FDA permits the use of placebo controls is hardly evidence that the FDA is overregulating.
You suggest the FDA overregulates mobile apps. In the last couple of years, it has sought to reduce, not enlarge, its regulatory oversight. For example, it has deregulated the hardware and software that takes data from medical devices like a blood glucose meter and transmits it for storage and display. That was a big step forward.
Instead of sweeping, fundamental reform to either clamp down or loosen up FDA oversight, I favor continuous improvement guided by continuous review of agency performance data as well as marketplace and scientific trends.
Mr. Thompson’s commentary during this roundtable was also featured in Healthcare Packaging, Med Device Online, and Plastics Today.
