July 2009 (09B-155)

Bulletin Summary       Under the provisions of legislation introduced earlier this year in the U.S. House of Representatives, manufacturers may soon face liability for medical devices that harm consumers, even if those devices received pre-market approval from the U.S. Food and Drug Administration (FDA). The proposed Medical Device Safety Act of 2009 would amend the Federal Food, Drug and Cosmetic Act to provide legal recourse to patients who are injured by a medical device that malfunctions.

Background

Under a 2008 ruling by the U.S. Supreme Court (Reigal v. Medtronic), individuals who claim injury due to the use of a medical device may not sue the manufacturer if the device received pre-market approval from the FDA. According to Representative Henry Waxman (D-CA), that ruling resulted in the dismissal of 1,400 separate lawsuits against device manufacturers.

The proposed legislation was introduced in the Senate as Bill S.540 by Senator Edward M. Kennedy (D-MA), and co-sponsored by 21 additional senators. A companion bill was introduced in the House of Representatives as H.R. 1346 by Representative Frank Pallone (D-NJ), and co-sponsored by 91 additional representatives.

Recently, the House Energy and Commerce Subcommittee has concluded hearings on H.R. 1346 and in the Senate, the legislation has been referred to the Committee on Health, Education, Labor and Pensions.

Text of Legislation

A summary of the text of S. 540 can be viewed at: http://www.govtrack.us/congress/bill.xpd?bill=s111-540
A summary of the text of H.R. 1346 can be viewed at: http://www.govtrack.us/congress/bill.xpd?bill=h111-1346

How Bureau Veritas Can Help

Bureau Veritas provides the necessary tools to meet certification requirements with an enhanced process. Our Curtis-Straus laboratory is an approved NRTL listed on the OSHA website (www.osha.gov/) and in Canada as listed on the SCC website (www.scc.ca/). Its employees are skilled in handling all aspects of testing, report writing, final reports, certification, initial plant inspections and follow-up service. This allows us to provide rapid turnaround, resulting in a shorter time to market and ultimately less expense. We can also provide you with the added convenience of arranging a transfer of existing Certifications.  Read more…

ISO 13485 defines the requirements that medical device manufacturers must incorporate into their management systems in order to achieve compliance in the medical device industry. Certification to this standard provides a solid framework on which to build compliance to various regulatory and customer requirements.  Read more…

  

Contact Information

If you have any comments and/or questions, please contact your customer service representative or email ElectricalMail@BureauVeritas.com.

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