For the past couple years, the Food and Drug Administration has been reviewing the regulatory process that most medical devices use to reach the U.S. marketplace, the 510(k) pathway. After delaying decisions last year on its own hot-button recommendations until the Institute of Medicine released its (very controversial) report this summer, the FDA recently made plans to decide on potential 510(k) changes by early October. If the FDA makes relatively modest changes to the 510(k) process, the regulatory uncertainty weighing on medical device stocks may dissipate, giving medical device shares an upward catalyst.
