The FDA's controversial fast-track device program is under fire after suggestions were made that product recalls were linked to poor testing practices. The 510(k) program was created to move medical devices that are similar to other devices already available to the market faster than normal. Some would argue that this process has allowed defective medical devices to enter the marketplace, putting consumers in Connecticut and nationwide at risk.
Because of complaints about the 510(k) program, the FDA plans to increase and enforce higher standards. However, the program will remain in place as an available option for manufacturers to reduce product development times. The biggest change that will be seen is the elimination of approving what are called split-predicate devices.