Fast-track clearance may soon hit a speed bump

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Since 1976, the government has allowed device makers to receive fast-track clearance. The process has been a boon to vendors, as it eliminates the need to conduct clinical trials that support safety and efficacy. But an internal Food and Drug Administration memo suggests the process needs to be tightened, and possibly eliminated. The memo follows several high-profile device malfunctions. Should changes be put in place, the result will be delays in the arrival of devices that could help the elderly live better lives, vendors say.

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