Now that you know how to utilize the databases available to you on the FDA Website, use either the Classification Database, the 510(k) Database, or the PMA Database to choose a medical device that interests you. In 3-5 pages, describe (In Summary) the Regulatory History of this device. Think about some of the questions below when summarizing this history. Be sure to include why you chose this device, and describe where the device information came from either through description or citation (or both). Feel free to include brief information regarding the device’s manufacturer if you feel it is appropriate. Information to Consider • For what purpose is this device intended for? • Is this a combination product? • What Class of Device is this? • How long has this device been on the market? • Has the device undergone any major changes since it was first placed on the market? • Have there been any safety concerns with this device? o Recalls? o Withdrawals? o Legal Actions? • Is there any indication that this device will be undergo any major changes in the future?
describe in summary the regulatory history of this device acl top 300 cts
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