FDA Aggressively Enforcing cGMP Violations for Devices
Over the last 18 months, the pendulum has swung back to aggressive FDA enforcement of current good manufacturing practices (cGMPs) for medical devices, Mark Brown, a partner with King & Spalding, said last week at the FDAnews Fourth Annual Medical Device Quality Congress.
“FDA hates being called on the carpet at congressional hearings and accused of allowing a product either [to enter] the market [if it has] had problems, or allowing a product to remain on the market if there are known safety issues associated with it,” Brown said.
If the FDA has concerns with a manufacturer’s cGMP compliance status and asks the firm what its intentions are for the relevant product, Brown said the agency is likely to consider removing the device from the market.
He also noted the importance of properly investigating product complaints, as one violation could taint an entire population of a manufacturer’s devices. That, in turn, has significant product liability implications.
“One of the reasons why that is hugely significant right now is in the product liability context where cases are actually being brought against companies [because] of FDA allegations [that] the device was adulterated or misbranded,” Brown said.
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