What Does the FDA do to Approve Medical Devices?

Asheville, North Carolina

The Food and Drug Administration is the federal agency tasked with approving medical devices, like hip implants, before they reach the market where consumers use them. However, some people may wonder in light of so many recalls, just how much does the FDA do to protect us from defective or harmful devices, like the Stryker hip implant or DePuy hip implant?

The truth of the matter is, it depends. Sometimes they do a lot, and sometimes they don’t go far enough.

Medical Device Classification

There are three classes of medical devices. These are:

  • Class I – present minimal harm to the user and are usually simple in design. Examples include hand-held surgical instruments, slings, and tongue depressors. These are exempt from premarket notification and compliance with good manufacturing practices regulation – because it is extremely unlikely you’ll be injured by one
  • Class II – Pre-market notification must be submitted to the FDA by the manufacturer, and the FDA will then review the manufacturer’s 510(k) clearance prior to market submission. Class II devices include surgical drapes, x-rays, gas analyzers, physiologic monitors, and more
  • Class III – Devices are for life support or sustainment, are very important to maintaining health, or present a potential risk of illness or injury to the patient. Applications of General Controls and Special Controls do not show sufficient information assuring safety and effectiveness in the usual way and absolutely must be submitted for pre-market approval to the FDA. Examples include certain implanted stimulators, heart valve replacements, and silicone breast implants

Class I devices must simply be registered with the FDA, but if no concerns are raised, the facilities where they are made is not inspected. Class II devices may have to show documentation, studies, and diagrams, but once the device is issued its 501(k), it is simply declared “FDA cleared,” but not “FDA approved.” The FDA takes the manufacturer’s word that their device is safe.

Class III devices involve clinical trials to test for safety and effectiveness, a series of studies, and vigorous oversight by the FDA before they are allowed to be sent to the general public. These are considered “FDA-approved.”

While it may seem obvious which category your failed hip implant goes in, it is important to speak with defective product attorneys McWhirter, Bellinger & Associates so that they can determine how your hip implant recall suit will progress.

If you or a loved one has been seriously injured by a defective product, including a hip implant, please contact McWhirter, Bellinger & Associates to speak with one of our experienced hip implant recall lawyers today.