FDA Safety Devices

HEHS-94-90R: Published: Feb 2, 1994. Publicly Released: Feb 2, 1994.

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Pursuant to a congressional request, GAO reviewed the Food and Drug Administration's (FDA) process for reviewing and approving safety devices designed to protect health care workers from injury and exposure to infections. GAO noted that FDA: (1) does not conduct clinical trials to assess the effectiveness or safety of a device as part of its review process; (2) takes an average of 272 days to review premarket notifications because it does not have sufficient staff to review manufacturers' documentation; (3) has experienced significant staff attrition due to voluntary staff transfers and resignations; (4) has required its reviewers to thoroughly document review determinations; and (5) has taken actions to reduce review times and backlogs including rejecting any applications that lack essential information, hiring three additional staff members, and issuing guidance on premarket notifications for other safety devices.

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