In December 2011, a new bill was introduced in the U.S. Senate that would require medical device manufacturers to monitor the performance of implant products, even after the medical devices are cleared for marketing by the FDA.
This new bill addresses the complaints from many patient advocate groups of the FDA’s 510(k) process, which they feel is the cause of thousands of failing all-metal hips. The 510(k) process used by the U.S. FDA allows a manufacturer to sell a new medical device by only showing that it is “substantially similar” to a product already on the market. This process is commonly used for the sale of certain implants, like artificial joints.
Though this new bill will not require any additional mandated FDA premarket testing, it would give FDA additional authority to force device makers to track and report the performance of such implants. The proposed bill would also tighten federal scrutiny of product recalls.
The goal of the bill is to better patient safety – – without slowing the process for device approval. The three senators that introduced the bill feel it is necessary for consumers of these medical devices. They are: Herb Kohl (D) of Wisconsin, Richard Blumenthal (D) of Connecticut, and Charles E. Grassley (R) of Iowa. They also sent letters to five major manufacturers of medical devices asking how they keep track of product safety and recall devices.
For more information on the proposed FDA bill, click here. As the bill goes through the legislative process, Registrar Corp’s team of experts will keep you up-to-date. If you have any U.S. FDA questions, feel free to contact us at +1-757-224-0177 or for immediate assistance go to www.registrarcorp.com/livehelp.