Device Makers Identify More FDA Regulations Worth Revising

Device makers have proposed several regulations that FDA should revisit to lighten manufacturers’ burdens as part of the agency’s ongoing regulatory review.

The Obama administration ordered federal agencies early this year to review their existing regulations to consider which rules should be repealed, revised or strengthened.

FDA identified more than 40 regulations to revisit, including some rules that are already being modified or streamlined. Among the priorities, the agency plans to transition toward an electronic adverse event reporting system, down-classify more devices to lower-risk categories and allow manufacturers to use validated symbols in labeling in place of English text. (See “ Agencies Launch White House-Mandated Review Of Regulations ” – “The Gray Sheet” May 30, 2011.)

Device stakeholders suggested in recent comments that FDA’s preliminary list is a good start, but that more policies also are ripe for revision.

Click here to read the full article