Devices & Diagnostics

Eye on Congress: Medical device bills to watch (Part 2)

Yesterday, I wrote a post about the various medical device bills in Congress that the medical device industry should closely follow. Here’s Part 2 of the Congress watch, which looks at bills introduced in the House that have no Senate companion. The information comes thanks to Elisabeth George, vice president of Global Government Affairs, Regulations […]

Yesterday, I wrote a post about the various medical device bills in Congress that the medical device industry should closely follow.

Here’s Part 2 of the Congress watch, which looks at bills introduced in the House that have no Senate companion. The information comes thanks to Elisabeth George, vice president of Global Government Affairs, Regulations and Standards at Philips Healthcare, who did a wrap-up of proposed legislation at the third annual  Medical Devices Summit  in Boston earlier this week.

Keeping America Competitive Through Harmonization Act of 2011 (HR 3230)
Status: Referred to the Subcommittee on Health

Medical device companies increasingly sell their products overseas where they have to navigate each country’s regulatory regime. This bill aims to alleviate that burden by requiring the Department of Health and Human Services, and thereby the U.S. Food and Drug Administration, to enter into agreements with certain countries  in order to harmonize regulatory requirements for premarket review, inspections and develop common international labeling symbols.

The bill was introduced by Congresswoman Cathy McMorris Rogers of Washington state and has nine co-sponsors. Here is the text of the proposed legislation.

FDA Renewing Efficiency From Outside Reviewer Management Act of 2011 (HR 3205)
Status: 
Referred to the Subcommittee on Health

This bill aims to expand third-party review of device applications and allows a third-party facility inspection program to be extended until 2017.

More specifically, it increases the number of devices that are allowed to be evaluated by third-party reviewers, requires the FDA to accept the recommendation of a third-party reviewer’s device classification if the agency hasn’t finalized a decision within 30 days of the reviewer’s recommendation, and requires FDA to regularly train and update the training of these third-party reviewers.

The bill was introduced by Rep. Erik Paulsen, a Republican from Minnesota and has 16 co-sponsors. Here is the original bill as introduced.

Modernizing Laboratory Test Standards for Patients Act of 2011 (HR 3207)
Status:  Referred to the Subcommittee on Health

This bill would require the Secretary of Health and Human Services to establish a publicly accessible test registry data bank of laboratory-developed tests and direct-to-consumer DNA tests. The data bank would include information on the purpose of each test, the claimed use or uses of each test and information regarding the analytical validity of each test, according to a summary of the bill.

The secretary would need to be notified prior to the test being marketed, significantly modified or if the clinical evidence supporting a claimed use is inadequate. If there is no response from the secretary within 90 days, the company can go ahead and market these tests.

Rep. Michael Burgess, a Texas Republican, introduced the bill and it has 16 co-sponsors. Here is the text of the proposed legislation

Guidance Accountability and Transparency Act of 2011 (HR 3204)
Status: Referred to the Subcommittee on Health

The medical industry believes that the FDA has been issuing more guidance documents than ever before and even regulatory attorneys are scrambling to keep up with these changes.

This bill requires that the public be notified that major changes are afoot three months before any so-called Level 1 document is issued. The notification would come via the Federal Register. The bill would also require a meeting with stakeholders before the documents are issued.

According to statute,  Level 1 guidance documents are those that:

  •  Set forth initial interpretations of statutory or regulatory requirements;
  •  Set forth changes in interpretation or policy that are of more than a minor nature;
  •  Include complex scientific issues; or
  •  Cover highly controversial issues.

The bill would also require a final version of a draft regulation to be completed within 12 months and urges that notice-to-industry letters be sent as part of guidance documents.

Rep. Brett Guthrie, a Republican from Kentucky, introduced the bill, which has eight co-sponsors. Here is the text of the proposed legislation.

Extension of Pediatric Medical Device Safety and Improvement Act of 2011 (HR 3975)
Status:  Referred to the Subcommittee on Health

This bill simply extends the provisions of the Pediatric Medical Device Safety and Improvement Act to 2017. The bill was introduced by Rep. Mike Rogers, a Republican from Michigan introduced the bill, which has one co-sponsor. Here is the text of the proposed legislation.

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