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Bennet, Isakson Introduce Bill To Modernize FDA Inspections Process

If interested in new regulatory compliance legislation to one of Arcam's target markets, read on. If not, don't waste your time (or ours).

Bennet, Isakson Introduce Bill To Modernize FDA Inspections Process - 02/17/2017

Washington, D.C. - U.S. Senators Michael Bennet (D-CO) and Johnny Isakson (R-GA) this week introduced a bipartisan bill 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 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 bill would establish a risk-based inspections process to ensure the frequency and nature of inspections are more consistent around the world. To do this, it would enhance 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.

Over 700 bioscience companies are located in Colorado, including biotechnology, diagnostic, digital health, and medical device companies, employing about 30,000 people. Colorado's medical device sector is the sixth largest in the nation.

With the support of the Advanced Medical Technology Association (AdvaMed), Senators Bennet and Isakson will work to advance this bill so patients are treated in a safer manner and FDA resources are used more efficiently.




The actual text of the bill isn't available right now but should be in a day or two. Check back on this link for updates.

Text: S.404 — 115th Congress (2017-2018)

As of 02/19/2017 text has not been received for S.404 - A bill to amend the Federal Food, Drug, and Cosmetic Act to improve the process for inspections of device establishments for granting export certifications.

Bills are generally sent to the Library of Congress from GPO, the Government Publishing Office, a day or two after they are introduced on the floor of the House or Senate. Delays can occur when there are a large number of bills to prepare or when a very large bill has to be printed.