A bill is pending in the House of Representatives regarding the FDA, Medical Devices and Information in the Public Safety Database
A bill remains pending in the House of Representatives that would allow the FDA (Food and Drug Administration) to reject an application for a new medical device, if it is modeled after an earlier device that had caused harm and was previously pulled from the market.
Two members of congress: Sen. Jeff Merkley (D-Ore.) and Rep. Edward Markey (D-Mass), have sent a letter to the Food and Drug Administration to assess their willingness to make certain changes if the bill is rejected, including:
* Is the FDA willing to update it’s 510(k) database to clearly indicate devices that have been recalled for design flaws that could adversely affect safety or effectiveness,
* Will the FDA update the database within 30 days after completing a review of a manufacturer’s root-cause analysis that concludes a flaw triggering a recall was serious, and could adversely affect safety or effectiveness?
* Include in the database clearly marked past recalls for serious design flaws that could affect safety and effectiveness, that is both comprehensive and informative regarding problematic predicates for both device manufactures and the public?
* Will the FDA revise the 510(k) Pre-market Notification database to notify the public that a certain product repeats the same design flaw that caused a predicate’s recall.
To read the letter in it’s entirety click here
