Regulatory Focus™ > News Articles > House to Consider MDUFA Add-Ons

House to Consider MDUFA Add-Ons

Posted 26 April 2017 | By Michael Mezher 

House to Consider MDUFA Add-Ons

With the deadline for reauthorizing the US Food and Drug Administration's (FDA) user fee programs rapidly approaching, members of the House Energy & Commerce Subcommittee on Health are considering a handful of device-related bills to include with the reauthorization package.

On Tuesday, the E&C subcommittee will discuss four bills that look to make hearing aids more accessible to patients over-the-counter, overhaul FDA's inspection program for device establishments, ease oversight of diagnostic imaging devices and strengthen oversight of companies that service medical devices.

"As we work toward advancing the FDA Reauthorization Act of 2017, it is important we consider some additional policies that will help patients and bolster this vital reauthorization," Subcommittee Chairman Rep. Michael Burgess (R-TX) said.

While the draft reauthorization bill released by House and Senate committees earlier this month closely mirror the agreements forged between FDA and industry, past user fee reauthorizations have been part of larger legislative packages.

For instance, the last user fee reauthorization was part of the Food and Drug Administration Safety and Innovation Act of 2012, which also included provisions for incentivizing antibiotic development, speeding access to drugs that treat serious or life-threatening diseases, as well as a number of "regulatory improvements" for medical devices.

While not included in the list of bills to consider during the hearing, Rep. Mimi Walters (R-CA) on Tuesday introduced a bill that would overhaul how medical device accessories are classified.

As detailed in FDA's recently finalized guidance on device accessory classification and included in the 21st Century Cures Act, FDA may classify new types of device accessories differently from their "parent" devices.

However, according to AdvaMed CEO Scott Whitaker, "FDA does not have a good mechanism for implementing this provision or for addressing the hundreds of accessories currently on the market that may be inappropriately classified."

To address this, Walters' bill would allow device makers to suggest a risk classification for new and existing device accessories to FDA, and require FDA to respond to requests within 30 days for new devices accessories and 60 days for already classified accessories.

Also absent from the agenda is whether a possible repeal of the medical device tax introduced under the Affordable Care Act will be discussed.

Energy & Commerce: Hearing, Notice


© 2021 Regulatory Affairs Professionals Society.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.