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Medical Devices › FDA Reauthorization Act

Mintz - Health Care Viewpoints

FDA User Fees: Highlights from FDARA & Our Forecast for the Next Round

Mintz - Health Care Viewpoints on

As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA) for another 5-year period is getting started this year. Below we highlight...more

Butler Snow LLP

Pro Te: Solutio – Vol. 11, No. 4

Butler Snow LLP on

Fall has descended upon us, along with that nip in the air and the aroma of pumpkin spice. All of these herald our latest edition of Pro Te: Solutio, which contains three fascinating articles on topics of current interest in...more

Arnall Golden Gregory LLP

Some May Come and Some May Go: FDARA Brings Changes to User Fees and Other FDA Programs

Arnall Golden Gregory LLP on

On August 18, 2017, the President signed the FDA Reauthorization Act of 2017 (FDARA), which revises and extends several of FDA’s user fee programs. The user fee programs establish filing fees for various application types and...more

Akin Gump Strauss Hauer & Feld LLP

A Client's Guide to FDA Inspections

Akin Gump Strauss Hauer & Feld LLP on

A Food and Drug Administration (FDA) inspector has just knocked on your door and announced that he or she will now inspect your facility. What happens before, during and after this inspection, and what should your firm do to...more

Hogan Lovells

FDA Announces New Device User Fees with Significant Increases for Some Submissions

Hogan Lovells on

On August 29, 2017, FDA published a Federal Register notice with the device user fees for the Agency’s Fiscal Year (FY) 2018, which begins on October 1, 2017. Due to statutory increases, inflation adjustments and target...more

Knobbe Martens

House Passes Bill Relaxing Reporting Requirements

Knobbe Martens on

The U.S. House of Representatives recently passed the FDA Reauthorization Act of 2017. This bill seeks to change the requirement for companies to report medical device malfunctions to the FDA. Previously, companies had to...more

Akin Gump Strauss Hauer & Feld LLP

Senate Passes Long-Awaited FDA User Fee Package

Akin Gump Strauss Hauer & Feld LLP on

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

Mintz - Health Care Viewpoints

August 2017 Is Here – Will FDARA Get Done Soon?

Mintz - Health Care Viewpoints on

It has been some time since we provided a detailed update on the status of FDA’s user fee legislation making its way through Congress, so that’s what is on tap for today. The House passed the lengthy FDA Reauthorization Act...more

Baker Donelson

House Advances Bipartisan FDA User Fee Agreements; Senate Faces Narrow Timeline to Act

Baker Donelson on

On July 12, the House passed a five-year reauthorization of four different user fee agreements that account for over a quarter of the Food and Drug Administration's (FDA) overall funding. The legislation, titled "The Food and...more

Saul Ewing LLP

House Passes FDA Reauthorization Act; Would Reauthorize Key User Fee Programs and Lengthen Medical Device Malfunction Reporting...

Saul Ewing LLP on

Last week, the U.S. House of Representatives (the House) passed by voice vote the FDA Reauthorization Act of 2017 (FDARA or the Act). Introduced on May 16, 2017 by House Energy and Commerce Committee Chairman Greg Walden...more

Faegre Drinker Biddle & Reath LLP

FDA House Legislation Would Relax Reporting of Medical Device Malfunctions

Faegre Drinker Biddle & Reath LLP on

On July 12, 2017, the U.S. House of Representatives passed a bill to reauthorize four of the U.S. Food and Drug Administration’s user fees and to change various drug and device testing rules. H.R. 2430 – the FDA...more

Baker Donelson

Washington, D.C. Update – June 2017

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Having returned from its Memorial Day recess, Congress now enters one of the longest continuous work periods of the year and – with the exception of the week of the Fourth of July – will likely be in session until the end of...more

Baker Donelson

Congressional Committees Advance Bipartisan FDA User Fee Agreements

Baker Donelson on

On May 11 and June 7, the Senate HELP Committee and House Energy and Commerce Committee, respectively, both advanced bipartisan legislation to reauthorize four different user fee agreements that account for over a quarter of...more

Mintz - Health Care Viewpoints

More Bipartisan Bills Hope to Catch a Ride on the UFA Reauthorization Legislation

Mintz - Health Care Viewpoints on

Just as the public comment period for the bicameral, bipartisan discussion draft of the “FDA Reauthorization Act of 2017” ended on Friday, what we have been calling the User Fee Games got even more interesting and engaging....more

Mintz - Health Care Viewpoints

Congressional Leaders Seek Input in UFA Reauthorization Draft Bill by April 28, 2017

Mintz - Health Care Viewpoints on

On April 14, 2017, leaders from the Senate HELP Committee and the House Energy & Commerce Committee released the first discussion draft of the 2017 FDA user fee reauthorization bill. As we’ve been reporting, these two...more

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