Old Medical Devices Need New FDA Approvals ~ OPOLAW Injury Blog

Monday, April 20, 2009

Old Medical Devices Need New FDA Approvals

Medical devices whose Class III approvals were grandfathered in during the 1970s must now go through the process of proving their safety.” The hope is to make the devices more marketable by reclassifying them into less-risky categories. The FDA has had three classes of devices, from non-risky Class I bandages to very-risky Class III pacemakers.

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