In Law360, Life Sciences Attorneys Examine FDA’s Proposed Medical Device Rule
In Law360, life sciences regulatory & compliance partner Joshua Oyster, counsel Beth Weinman and associate Austin Laroche (all of Washington, D.C.) analyzed the U.S. Food and Drug Administration proposed rule to harmonize its regulations governing good manufacturing practices for medical devices with an international consensus standard, ISO 13485.
The authors note that despite general industry support for the proposed rule, the overwhelming theme from industry stakeholders so far is that one year is not enough time to transition to the international standard.