The Food and Drug Law Institute has released a report that urges the FDA to reform the 510(k) approval process for medical devices.
The report states the approval process currently does not ask the right questions to determine whether there is reasonable assurance that the device will be safe and effective.
FDLI suggests that the FDA create a standard that distinguishes between devices for which postmarket controls are sufficient and those for which a full premarket safety and effectiveness assessment is needed. The standard should also promote innovation, the report said.
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The report states the approval process currently does not ask the right questions to determine whether there is reasonable assurance that the device will be safe and effective.
FDLI suggests that the FDA create a standard that distinguishes between devices for which postmarket controls are sufficient and those for which a full premarket safety and effectiveness assessment is needed. The standard should also promote innovation, the report said.
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St. Jude Medical Plans to Double its Location in Plymouth, Minnesota
FDA Clears Intuitive Surgical Vessel Sealer for da Vinci Surgical System
Top 3 Reasons Behind the Drug Shortage Nightmare