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News and Press: Policy News

Federal Policy Advocacy Alert: March 4, 2014

Tuesday, March 4, 2014   (0 Comments)
Posted by: Stephen Rapundalo
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Not much change with FDA's new 510(k) device modification rules
In its report to Congress, the FDA Center for Devices & Radiologic Health's (CDRH) proposed changes to the medical device 510(k) modification review process would leave rules generally intact, rather than pursuing the major overhaul proposed three years ago. 

The executive summary states that the FDA "intends to make targeted revisions to the 1997 guidance" rather than attempt to come up with an entirely new framework. Furthermore, the CDRH promised that the agency "intends to adopt a policy that will leverage existing quality system requirements" to deal with changes to 510(k) devices.  

This is good news for the medical technology sector, as there were plenty of ruminations and ominous indications that the 510(k) review process was slated for complete gutting. Nevertheless, "the devil's in the details" adage applies to this document as device companies seek clarity on issues like predicate drift, product testing, flowcharts, software, and substantial equivalence. National trade groups AdvaMed, Medical Device Manufacturers Association (MDMA), and Medical Imaging & Technology Alliance (MITA), along with the state medtech associations like MichBio will continue to be engaged on the issue especially as the FDA develops eventual draft guidance.

MichBio visits capitol hill on medical device issues
MichBio CEO Stephen Rapundalo and Gene Parunak, General Director at in2being, visited Capitol Hill last week as part of the AdvaMed Legislative Fly-In. A total of twelve meetings were arranged with congressional staff and/or legislators. Along the way, several impromptu meet ups in the hallways, cafeteria, etc. made for a very productive schedule. 

On Wednesday, Stephen and Gene met with Rep. Benishek and the healthcare legislative assistants in the offices of Reps. Rogers and Upton. Then, it was off to a legislative briefing at AdvaMed where they joined executives from 20 states and 23 organizations. Stephen led that briefing in his role as Chair of the State Medical Technology Alliance (SMTA), a collection of state medtech associations that represent the interests of U.S. medical device and diagnostics companies. Participants were updated on the latest legislative and regulatory policy matters, including repeal of the medical device tax, FDA user fee sequestration and FDA review processes. 

The next day began with a two-hour Breakfast Briefing between AdvaMed, SMTA executives and DC Directors (or their representatives) of state Governors Offices. A three-person expert panel spoke on healthcare policy, medical technology innovation, and economic growth. The briefing concluded with a robust discussion on several issues raised by panelists including messaging to Congress and investment in workforce development. 

Then, it was back to Capitol Hill for an additional nine meetings - with staff in the offices of Reps. Huizenga, Levin, Peters, Camp, Conyers, Dingell, and Sen. Levin; along with direct meetings with Sen. Stabenow and Rep. Kildee. Jeremy D'Aloisio of G2G consulting (a MichBio Preferred Provider) joined the group for those visits. Discussion with staff/officials centered on a status report issued by AdvaMed that revealed findings of a survey on the impact of the medical device tax since its implementation 12 months ago. Gene Parunak provided a great narrative from a small company perspective that resonated with each of the offices...nothing like real stories from street level to catch the interest of policymakers.

Rep. Camp's tax reform package includes medical device tax repeal
On Wednesday, February 26, House Ways and Means Committee Chairman David Camp (R-Mich.) released his plan for U.S. federal tax reform by introducing draft legislation called the "Tax Reform Act of 2014." A key priority within the proposal is to roll back the medical device tax as part of an effort to control healthcare costs.

The tax reform proposes to simplify the Internal Revenue Code and strengthen the economy by lowering tax rates. The proposal recommends significant tax rate cuts for individuals and businesses and attempts to pay for such rate reductions by curtailing or eliminating individual and business tax breaks.

Revised FDA draft guidance on distributing scientific publications
The FDA announced the availability of a revised draft guidance for industry entitled, "Distributing Scientific and Medical Publications on Unapproved New Uses - Recommended Practices." This draft guidance revises the final guidance published in January 2009. The draft guidance provides the FDA's current thinking on recommended practices for drugs or medical device manufacturers and their representatives to follow when distributing scientific or medical journal articles, scientific or medical reference texts, or clinical practice guidelines (CPGs) to healthcare professionals or health care entities.

Electronic or written comments on the draft guidance should be submitted by May 2, 2014 to and refer to the docket number. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Further details on communications with the FDA are noted in the Federal Register notice.

Join MichBio on capitol hill - sign up for the BIO Legislative Fly-In
Once again MichBio is headed to Capitol Hill for the annual BIO Legislative Fly-In. We welcome our member companies to join us and participate in a unique experience to influence our Congressional delegation on bio-industry issues. Your engagement does make a huge difference!

BIO's 2014 Fly-In will occur April 8-9, 2014, and we are looking forward to another great day of policy engagement. Attendees are provided with a robust legislative briefing prior to their visits on Capitol Hill, where they will meet in small groups with the congressional members and senior staff of the attendee's congressional delegation. A BIO staff representative will accompany each group to all visits. 

There is no registration fee for those attending the Legislative Day Fly In. However, you are responsible for your own lodging, travel, and meal costs. Make your travel plans soon as the hotel block will go quickly.  

Interested individuals can find more information at the following links: 
Contact Stephen Rapundalo, President and CEO of MichBio at with any questions.

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