FDA is drawing a lot of fire these days, yet it deserves kudos for establishing its Medical Device Innovation Initiative, a priority review program for breakthrough medical devices.

Having said that, AdvaMed, too, deserves praise for its well-crafted, eight-page critique of the effort, which it issued last month. The AdvaMed document is expansive and includes specific comments on each of the three major components of the FDA initiative:

• Facilitate the development and regulatory evaluation of innovation medical devices via a Priority Review Program for Pioneering Technologies (innovation pathway) and the streamlining of the De Novo pathway.

• Strengthen research and regulatory science via third-party certification program for US medical device test centers; creation of core curriculum for device development and assessment; leveraging of device experience and data collected outside the US; and development of new science.

• Preparation for and response to transformative technologies and scientific breakthroughs via technology forecasting and the establishment of CDRH network of experts.

The complete document can be accessed via my blog at http://blog.medicaldesign.com/perspectives/. Then click on “AdvaMed calls on FDA to show more initiative on its initiative.”

The bottom line is that AdvaMed, Medical Design, and virtually anyone or anything involved in the future of the US medtech industry is encouraged by FDA efforts to foster medical device innovation. However, the one or two devices that CDRH chooses to focus on annually as part of the initiative will be insufficient and as AdvaMed states, CDRH “could expand the proposed priority review program to expedited devices and devices approved through CDRH’s Humanitarian Device Exemption (HDE) pathway, and then ultimately expand the program to all devices.”

Should FDA choose to act upon the AdvaMed critique to improve its Innovation Initiative, it will be proof positive that the agency takes seriously the second part of its two-part mission of ensuring the safety of medical devices while fostering an environment for innovation.

By the way, the first submission to be reviewed is a brain-controlled, upper-extremity prosthetic that will serve as a pilot for the program.

While we’re at it, kudos to the Government Accountability Office (GAO) for its investigation into FDA’s management of its medical device review, postmarket monitoring, and the recall processes. During a recent hearing on the agency’s role in protecting patient safety as part of the medical device approval process, GAO’s director of the Health Care Team, Marcia Crosse, outlined the preliminary findings of the ongoing GAO investigation and shined a bright light on gaps in postmarket surveillance, resulting in the use of unsafe and ineffective devices despite recalls.

For more on the hearing, check out Sherrie Conroy’s blog at http://blog.medicaldesign.com/perspectives/. Click on “Senate hearing takes device approval process to task, advocating for further reforms.”

Again, how FDA responds to such investigations will speak volumes about its commitment to fulfilling its mission.

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