FDA holds hearing on medical devices

The Food and Drug Administration (FDA) is evaluating the approval process for medical devices and is holding a day-long meeting February 18 to allow manufacturers, physicians, and consumer groups to weigh in.

The Food and Drug Administration (FDA) is evaluating the approval process for medical devices and is holding a day-long meeting February 18 to allow manufacturers, physicians, and consumer groups to weigh in.

The Wall Street Journal reported earlier in the week that the FDA may tighten or get rid of the 510(k) fast-track approval process because of safety concerns, while Senator Chuck Grassley issued a letter asking the agency for an update on new guidelines for medical device companies.

In Minnesota, members of the local medical device industry met to talk about the possibility of a tightened approval process and new regulations.

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