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The unjust process for FDA certification

Posted on: February 18th, 2016 by Romanucci & Blandin

Did you know the FDA regulatory process for medical devices is much shorter and, generally, less rigorous and costly than the FDA process for a new drug approval?

This is true.

To have a drug approved, it is estimated that the average length of time from concept to market for investigational new drugs is about 12 years. Yet the time from concept to market for medical devices is three to seven years.

We can’t help but wonder, why is there such a difference? Where are the checks and balances for medical devices? And furthermore, who is watching the physicians to make sure they use these devices correctly?

In our research, within the framework of the Medical Device Amendments of 1976 to the Federal Food Drug and Cosmetic Act, many new regulated devices are catalogued as Class III, which is defined as a device that ‘supports or sustains human life or is of substantial importance in preventing impairment of human health or presents a potential, unreasonable risk of illness or injury’. But, manufacturers are able to petition their device to be downgraded to Class I or II, which ultimately means a possible lower risk. Therefore, unlike the drug development pathway that mandates successful results in all three clinical phases to obtain new drug approval, the medical device pathway has separate fast-track routes of obtaining approval.

Also within our research, we investigated to find information on how or who supervises physicians to make sure they are using these devices correctly, without luck. After the initial training of these devices, who continually oversees these physicians? Should there be a protocol on how many times a physician should be overseen before becoming considered an expert in using this device?

Romanucci & Blandin strongly believes the FDA should have a more arduous approving system before allowing these devices to touch a patient for procedures and should have a more structured inspection program for the physicians who use them. For the most part, the FDA reporting process is dependent upon physicians reporting any events back to the company and “it is probably fair to say that, currently, such reporting is sporadic at best.”

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