Devices & Diagnostics

Eye on Congress: Medical device bills to watch (Part 1)

Congress is grappling with several bills this year that should be of particular note to the medical device industry. This summary covers all bills that have being considered in both chambers of Congress. The information comes courtesy of  Elisabeth George, vice president of Global Government Affairs, Regulations and Standards at Philips Healthcare, who reviewed current legislation […]

Congress is grappling with several bills this year that should be of particular note to the medical device industry. This summary covers all bills that have being considered in both chambers of Congress. The information comes courtesy of  Elisabeth George, vice president of Global Government Affairs, Regulations and Standards at Philips Healthcare, who reviewed current legislation in the third annual Medical Devices Summit in Boston earlier this week. (Part 2 will look at other House Bills that have no Senate companion)

1. Premarket Predictability Act of 2011 (HR 3209)
Status: Referred to the Subcommittee on Health
Companion bill: S1700

The bill should make the review process easier to predict, a problem that the industry has been talking about for several years. According to the summary of the bill, it would require the Secretary of Health and Human Services to:

  • Determine the least burdensome appropriate means of evaluating medical device effectiveness that would have a reasonable likelihood of resulting in approval.
  • Document the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding device review, approval, or exemption. Sets forth appeal procedures.
  • Regularly publish detailed decision summaries for each clearance of a device not requiring premarket approval.
  • Assign a tracking number to a medical device upon submission of: (a) an application for an exemption of a device for investigational use, (b) a request to classify a device, or (c) a premarket report or notification related to a device.

Here’s the  text of the bill  as introduced.

2. Novel Device Regulatory Relief Act of 2011 (HR 3203)
Status: Referred to the Subcommittee on Health
Companion bill:  S1943

This bill is aimed at streamlining the de novo review process such that low-risk devices can be commercialized quickly. Currently, a low-risk product that did not show substantial equivalence to something already approved has to be cleared using the lengthy premarket approval process. And the company/applicant has to wait until the device has been deemed a Class III before it can formally request that such a classification is inappropriate for such a low-risk device. The bill would eliminate this waiting period.

The summary notes that it would “revise the process for requesting classification for a type of medical device that has not been previously classified by removing the requirement that a person can only file a request for classification of a new medical device after the Secretary of Health and Human Services classifies the device as a Class III device in response to the person filing a notice of intent to market the device.”

Here’s the text of the bill  as introduced.

3. Safety of Untested and New Devices Act of 2012 (HR 3847)
Status: Referred to the House Committee on Energy and Commerce
Companion bill: (S1995)

This appears to be the only medical device bill in the House to be introduced by a Democrat (this one by Edward Markey of Massachusetts) and the aim is patient safety.  The bill would allow the U.S. Food and Drug Administration to reject an application based on a 510(k) predicate device that was ultimately recalled. This is another one that the industry should closely follow given that the vast majority of devices are approved through the 510(k) process and most recalls of products are 510(k)-cleared products.

Here’s the text of the bill as introduced.

4. Humanitarian Device Reform Act of 2011 (HR 3211)
Status: Referred to the Subcommittee on Health.
Companion bill: S1865

This is another bill the industry should cheer about. It removes profit prohibitions on devices approved under the Humanitarian Device Exemption. Currently, devices approved under HUD cannot be sold for more than what the company spent in R&D, fabrication and distribution.

Here’s the official legislation as introduced.

5. Patients Come First Act of 2011 (HR 3208)
Status: Referred to the Subcommittee on Health
Companion bill: S3847

This bill would require the FDA to finish evaluation of pre-amendment devices. The summary notes that within 90 days of the bill’s enactment, the FDA would establish a schedule “for the promulgation of regulations requiring premarket approval for medical devices required to remain in Class III” and then issue a final regulation within a year after such a schedule is established.

In addition, the bill has certain provisions related to device recalls, most importantly to develop a “detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall”, and “document the basis for each Food and Drug Administration (FDA) termination of a device recall.”

Here’s the official document as introduced.

6. Cultivating Scientific Expertise to Foster Innovation for Patients Act of 2011  (HR 3206)
Status: Referred to the Subcommittee on Health.
Companion bill: S2113

This bill may get consumer safety advocates a little riled up. It centers on conflict of interest among advisory panels that recommend approval or rejection of an application to the FDA’s Center for Devices and Radiological Health. One of the provisions specifically repeals a previous rule that applies to the FDA that prohibits anyone who has a financial interest, or an immediate family member with a financial interest, in a company or topic from being part of an advisory panel evaluating that company’s product.

The Senate version of the bill would create a chief innovation officer and a management review board at the FDA.

Here’s the text of the House bill as introduced.

7. Food and Drug Administration Mission Reform Act of 2011 (HR 3214)
Status: Referred to the Subcommittee on Health
Companion bill: S1972

This bill also aims to increase transparency and predictability in the regulatory sphere. The bill revises the mission of the FDA to ensure “that regulations are accessible, consistent, transparent, written in plain language, and easy to understand”  and that the administration “measures, and seeks to improve, the actual results of regulatory requirements.”

Here’s the text of the bill as introduced.

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