The full House of Representatives could vote on the 21st Century Cures Act as early as Thursday after the House Rules Committee meets to consider possible amendments to the bill.
As written, the massive overhaul bill H.R. 6 would allow a single central review board to monitor multiple trial sites, thereby reducing the complexity of U.S. clinical trials of medical devices. Currently, these studies must be cleared by a local IRB at each research site.
In addition, the bill would permit FDA-accredited third parties to conduct inspections when a devicemaker submits minor device design changes, such as those made under a 30-day or special PMA supplement.
The audit provision hews closely to the ongoing Accredited Persons Inspection Program, which was first authorized as part of device user fee legislation in 2002. Success in a third-party audit replaces a regular FDA inspection (IDDM, May 15).
The House Energy & Commerce Committee voted unanimously to send the bill to the full House in May. No similar legislation exists in the Senate, but House members hope to have the bill on the president’s desk by the end of the year.
Read H.R. 6 here: www.fdanews.com/7-15-HR6.pdf. — Elizabeth Hollis