Legislation introduced in February, H.R. 3847, would permit FDA to reject an application for a new device if it is modeled after an earlier product that was pulled from the market after causing harm. The bill remains pending in the House of Representatives.
In the absence of legislation being enacted, Rep. Edward Markey (D-Mass.) and Sen. Jeff Merkley (D-Ore.) have sent a letter to the FDA with several questions to assess the agency’s willingness to make certain changes, including:
* Update the 510(k) database to clearly indicate devices that have been recalled for design flaws that could affect safety or effectiveness,
* 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,
* Include in the database clearly marked past recalls for serious design flaws that could affect safety and effectiveness, and
* Revise the 510(k) Premarket Notification database to notify the public that a certain product repeats the same design flaw that caused a predicate’s recall.
Text of the letter is available here.