Good read: https://www.fda.gov/downloads/About...uctsandTobacco/CDRH/CDRHReports/UCM626352.pdf
1. The FDA has increased its oversight through additional device inspections
2. The FDA has taken a targeted, risk-based enforcement approach to address specific device areas of concern
3. The FDA’s focus on violative products and adverse event reporting during inspections has led to an increase in voluntary recalls and adverse event reporting
4. Most firms have corrected violations on follow-up inspection
5. The FDA has taken steps to promote device quality not just compliance with regulations
.
1. The FDA has increased its oversight through additional device inspections
2. The FDA has taken a targeted, risk-based enforcement approach to address specific device areas of concern
3. The FDA’s focus on violative products and adverse event reporting during inspections has led to an increase in voluntary recalls and adverse event reporting
4. Most firms have corrected violations on follow-up inspection
5. The FDA has taken steps to promote device quality not just compliance with regulations
.
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