Lawmakers propose bill to revamp FDA's medical device inspections

Senators this week introduced a bipartisian bill that would update the Food and Drug Administration's process for inspecting medical devices.

The bill — sponsored by Sens. Michael Bennet, D-Colo., and Johnny Isakson, R-Ga. — would develop a risk-based inspections process to ensure the frequency and quality of medical device inspections are more consistent on a global level, according to a statement on Sen. Bennet's website.

The senators hope the bill will boost communication between the FDA and devicemakers, while also improving the process for granting export certificates to companies seeking to market their products abroad.

"The current device facility inspection process lacks transparency, predictability and consistency between facilities," said Sen. Isakson in a statement. "This bill is designed to improve communication and consistency in the device facility inspections process, which will allow both FDA and device manufacturers to make more efficient use of resources."

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