Senate Bipartisan Bill to Reform FDA’s Medical Device Inspection Process

On Wednesday, February 15th, Senators Michael Bennet (D – CO) and Johnny Isakson (R – GA) introduced a bill to improve FDA’s medical device inspection process.  If passed, the bill would amend the Federal Food, Drug, and Cosmetic (FD&C) Act, to establish “a risk-based inspections process to ensure the frequency and nature of inspections are more consistent around the world, states the press release from Senator Bennet.

Additionally, Mark Brager, President and CEO of Advanced Medical Technology Association (AdvaMed), notes that “the legislation would also:

• Establish a process for companies to address deficiencies more quickly and robustly;
• Create a more focused and efficient inspection process for FDA;
• Harmonize the inspection process to eliminate regional variations; and
• Improve communications between FDA and companies to ensure timely implementation of any remediation plans.”

According to Mr. Brager’s statement, “both the medical technology industry and FDA recognize the need for a robust inspections process to help ensure the continued availability of safe and effective devices and diagnostics for patients.” However, due to a lack of consistency, predictability and transparency, FDA’s current inspection process is simply not getting the job done.

In a recent statement, Senator Isakson noted that “the current device facility inspection process lacks transparency, predictability and consistency between facilities.” Furthermore, he explained that “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.”

If passed, this bill would allow FDA to use its resources in a more efficient manner and ensure patient safety when using medical devices.  It will be very interesting to watch as this bill makes its way through the legislative system.  We will provide updates as they become available.

Do you manufacture a medical device or any other type of FDA-regulated product? As the process changes, we can help ensure that your product will pass all of FDA’s inspections. For additional information on our services and how we can help you, contact us today.