Senators Look to Overhaul Medical Device Inspections

Regulatory NewsRegulatory News | 21 February 2017 |  By 

Sens. Johnny Isakson (R-GA) and Michael Bennett (D-CO) have introduced a bill that looks dramatically alter the US Food and Drug Administration's (FDA) process for inspecting device manufacturers.

Specifically, the bill calls for FDA to implement a more consistent, risk-based inspection process, as well as to improve communications with device makers regarding inspections and findings.

"The current device facility inspection process lacks transparency, predictability and consistency between facilities," Isakson said. "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."

According to the bill, inconsistencies in how inspections are conducted across FDA's foreign and domestic offices create challenges for device makers.

"The frequency and nature of inspections of device establishments are not consistently risk-based and a comprehensive, transparent, risk-based approach to inspections would result in greater focus on more significant risks to public health while reducing the burdens on establishments with a strong track record of compliance," the bill states.

As part of the risk-based framework for inspections, the bill would require FDA to consider a device maker's participation in US-recognized international device audit programs when determining inspection scheduling.

As for changes to the inspections themselves, the bill would require FDA to notify the device maker in advance of the type and nature of the inspection, in a reasonable amount of time before the inspection takes place.

For routine inspections, FDA would also be required to provide device makers with an estimate for how long the inspection is expected to take, and participate in daily communications with the company's owners or operators. And, when possible, FDA is instructed to give device makers advanced notice of the records they will request as part of the inspection.

Additionally, the bill would also compel FDA to give device makers feedback on proposed actions to address issues cited in a Form 483 following an inspection within 45 days of receiving the request.

If enacted, the bill would require FDA to issue draft guidance within a year specifying how it would implement the bill. Specifically, the draft guidance would detail standardized templates for the various communications described in the bill, establish a standard timeframe for inspections and detail a set of common set of practices for investigators.

The Advanced Medical Technology Association (AdvaMed) supports the bill.

"The legislation … will help modernize FDA's inspections process through a risk-based approach that will focus the agency's limited resources on facilities that have the most potential to impact public health, improving overall patient safety," said AdvaMed CEO Scott Whitaker.

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Tags: Inspections

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