According to a Food and Drug Administration 2015 performance report, the FDA’s approval rate for high-risk medical devices jumped to 98 percent for medical devices submitted within the most recent fiscal year. This was a 12 percent increase from the previous year and an almost 30 percent approval percentage increase from 2012. These devices were submitted through the FDA’s “premarket approval” pathway (PMA), which is designed for the review of the most high-risk “Class III” medical devices such as gastric balloons, heart valves, cancer tests, spinal implants, and similar devices.
The approval rate, which is a 15 year high, is hypothesized to be due to pressure from Congress to reform the FDA’s approval process. PriceWaterHouseCoopers reported that the approval process was a major source of frustration in 2009 and 2010 when approval rates dropped as low as 68% and 59% respectively. Medical device manufacturers responded by advocating for approval pathway reform legislation. This advocacy led to approval pathway reforms in the 2012 FDA Safety and Innovation Act. The increase in approval percentages from 59% in 2010 to 98% in the most recent fiscal year may support the agency’s contention that additional proposed reform legislation in the form of the 21st Century Cures Act is unnecessary.
The approval rate for lower-risk devices has also benefited from recent changes in the FDA approval process. The FDA approved 85 percent of all 510(k) device applications in the most recent fiscal year, the highest rate since 2010. Examples of lower-risk devices include I.V. catheters, blood glucose monitoring systems, and others.
In addition to higher approval rates, the FDA reported a significant decrease in the average time for FDA decisions on PMA and 510(k) device applications. The average time for an FDA decision on a PMA application declined from an average of 432 days in 2013 to a 14-year low of 262 days in 2014.* For 510(k) device applications, the average time for an FDA decision dropped to a 10-year low of 95 days in 2015 from 126 days in the previous year.
The improvement in the FDA regulatory process may encourage new investment in the medical device industry in the U.S., especially by companies and investors who have traditionally favored Europe’s less stringent CE Mark regulatory approval process.