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Medical Device Group Mirrors Congress in Efforts to Improve FDA Regulation

Posted 11 February 2015 | By Alexander Gaffney, RAC

Medical Device Group Mirrors Congress in Efforts to Improve FDA Regulation

The US's largest medical device trade group, AdvaMed, has unveiled a new "Innovation Agenda" it hopes will complement legislative efforts meant to improve the way in which the US Food and Drug Administration (FDA) regulates medical devices.


The agenda, released on 10 February 2015, is part of a larger push to "renew [the] medical technology innovation ecosystem," AdvaMed explained in a press statement. The ultimate goal of the initiative is to "help speed patient access to the next generation of life-changing innovations," the group added.

That push comes just as the US House of Representatives and Senate are working on separate but related measures to overhaul how FDA regulates medical products. While the Senate has only released a whitepaper on its efforts, the House Energy and Commerce Committee has put together an early draft of its proposed 21st Century Cures Act.

For a complete explanation of the 21st Century Cures Act, please read our explainer here.

AdvaMed's report focuses in part on the way in which FDA regulates medical technologies, with several high-level proposals which bear substantial similarity to language contained within the House's 21st Century Cures Act.

21st Century Support

For example, one area of focus for AdvaMed is the revitalization of FDA's "least burdensome standard," which (from the perspective of the device industry) is intended to ensure that devices are subject to an appropriate degree of regulation. The goal has won some support in Congress, which included language in Section 5063 of the 21st Century Cures Actdraft to train FDA regulators on the approach.

AdvaMed's goal mirrors the Cures Act in calling for FDA regulators to be encouraged to use "valid scientific evidence from such sources as registries, experience in foreign markets, and peer-reviewed journal articles, where appropriate, to support safety or effectiveness determinations."

Another proposal familiar to readers of the draft 21st Century Cures Act relates to allowing device companies to self-certify "minor changes to devices if their quality system has been certified as capable of evaluating such changes." The 21st Century Cures Act contains a similar proposal, although it is focused on third-party—not first-party—review of changes.

Looking at MDUFA

Not all of AdvaMed's proposals are related to the Cures Act. In fact, AdvaMed's top effort appears to be related to an entirely separate piece of legislation long known to industry: the fourth re-authorization of the Medical Device User Fee Act (MDUFA IV).

With the negotiations process for the 2017 reauthorization of MDUFA set to begin by the end of the year, AdvaMed says it hopes it can ensure that FDA is meeting its expectations for the current iteration of MDUFA, which was passed in 2012 under the Food and Drug Administration Safety and Innovation Act (FDASIA).

The 2012 MDUFA agreement substantially raised fees on medical device application submissions and facility inspections, which were intended to help fund FDA. In return, FDA promised to hire and train more staff to review device applications, and to review those applications according to established standards.

Other Measures

AdvaMed said it also wants to encourage FDA to "accept international consensus standards," though the agenda does not clarify what it means by that statement. FDA already regularly adopts standards developed by third-party organizations like the International Organization for Standardization (ISO), which the agency refers to as "recognized consensus standards."

Other regulatory efforts include streamlining the CLIA [Clinical Laboratory Improvement Act] waiver process to make it easier to market diagnostic products; allowing the use of central Institutional Review Boards (IRBs) in multi-center clinical trials; encouraging the development of devices to treat rare and pediatric diseases; working to make sure post-approval surveillance does not include "unnecessary burdens" on companies; and making sure the Unique Device Identification (UDI) system is implemented smoothly.


Read AdvaMed's Innovation Agenda document here. (Press)

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