FDA modifying medical device process

February 11, 2019
medical-device-process-blog

The Food and Drug Administration has proposed new guidance for the approvals process for medical devices.

For more than 40 years, device makers obtained an expedited approval if they could prove the new device was “substantially equivalent” to one in use when the regulation went into effect in 1976, according to a report by CNBC.

The change is designed to encourage manufacturers to base new products on devices no older than 10 years.

The change will not directly affect BioBridge Global and its subsidiaries, as we don’t manufacture or market medical devices at this time directly, said Adrienne Mendoza, Vice President for Global Quality & Compliance.

“It may be that the changes provide an opportunity for BioBridge Global to help device developers in It could drive business for us to study testing the clinical safety and efficacy of devices for filings that can no longer leverage a substantial equivalence,” she said.

According to the CNBC report, the FDA cleared 3,173 devices last year, with more than 8 in 10` of all the devices cleared or approved, the FDA said in a statement. The proposed guidance for the alternative pathway to approval is available on the FDA website.

The final guidance is expected to be released in early 2019.

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