Bi-Partisan Bill to Streamline FDA Device Inspection Process

The FDA inspection process for device manufacturers is getting some bi-partisan attention in Congress.

On February 15, 2017, U.S. Senators Michael Bennet, a Democrat from Colorado and Johnny Isakson, a Republican from Georgia introduced a bipartisan bill (S.404) to modernize the FDA’s medical device inspections process.

“FDA inspections are supposed to ensure that companies provide safe and reliable medical devices for patients around the world,” Bennet said. “This bill would modernize that process, streamline consistent inspections across regions, and implement recommendations more quickly.”

The legislation is called, “A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.”

“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.”

The Senators want to stablish a “risk-based inspections process” to make sure the frequency and nature of inspections are more consistent around the world. To do this, the bill requires enhanced communication between the FDA and companies so they may address quality and compliance issues more efficiently. The bill would also improve the process for granting export certificates to foreign countries for companies that seek to market their devices internationally.

Specifically, 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, the FDA would have to give device makers an estimate for how long the inspection is expected to take, and communicate daily 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 require the 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If the bill gets through Congress and is signed by President Trump, the FDA would have to issue draft guidance within a year specifying how it would implement the bill.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.

To read the text of the legislation, click here.