US FDA ramping up permanent 510(k)

 US FDA ramping up permanent 510(k) on Monday finalized guidance explaining when it considers micro needling devices to be medical devices subject to premarket notification (510(k)) requirements. The US Food and Drug Administration has permanently exempted seven types of low-risk medical devices from 510(k) premarket notification requirements, and has proposed similar exemptions for several other device types to expand access to these products during the COVID-19 public health emergency. 

US FDA ramping up permanent 510(k)

The US Food and Drug Administration has permanently exempted seven types of low-risk medical devices from US FDA ramping up permanent 510(k) premarket notification requirements, and has proposed similar exemptions for several other device types to expand access to these  products during the COVID-19 public health emergency. The devices identified. According to a recent FDA notice, the seven Class I device types permanently exempt from US FDA ramping up permanent 510(k) requirements include surgical and examination gloves. In response to the COVID-19 outbreak, many medical device market regulators are releasing Emergency Use Authorizations (EUAs) and expedited regulatory pathways for devices healthcare providers need most, including ventilators, face masks and PPE, and test kits, among others. Some authorities are reclassifying products to streamline market entry and avoid shortages. 

Under EUA declarations, FDA has the authority to authorize rapid emergency use of specific devices via expedited premarket review during public health crises such as the Coronavirus pandemic. Ability of FDA’s part to determine via risk-benefit analysis the device’s known and potential benefits regarding treating, diagnosing or preventing COVID-19

“To date, the FDA has only granted marketing authorization for a limited number of medical devices for specific uses in specified areas of the face and body. The FDA may not have reviewed the use of certain micro needling devices for all locations in the body,” 

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