The Food, Drug and Cosmetic Act was amended, in 1976, to add regulation of medical devices. A well-intended law has now caused unintended consequences. The FDA views the medical device industry and politicians as its customers, instead of the public; relies on the honesty of what is presented by industry and their paid consultants; and does what politicians direct the FDA to do.
The FDA must approve new medical devices and indications as submitted, or reject the device entirely–a politically unpopular outcome. The FDA cannot narrow requested indications, and can only require a warning in labeling (often not seen or read) that the FDA approval exceeds what is proven safe and effective, or the effect is temporary. Ninety percent or more of medical devices on the market obtained a clearance to market, NOT an FDA approval. The medical devices were grandfathered onto the market, in 1976; or have a clearance to market based on a claim of “substantial equivalency” to a device marketed before 1976. The FDA does not adhere to its own requirements in reviewing marketing clearances, including the requirement of a full review and approval for any product with a change in design or materials, which raises new questions of safety or efficacy.
The FDA has chosen to adopt a less rigorous standard for approval and market clearance of, “it’s better than what we have now”. The FDA has cleared devices as substantially equivalent, with minimal review, even when predicate devices were known to be dangerous and even when the predicate devices had been removed from the market due to the harm caused. FDA monitoring of adverse events after marketing is ineffective; and the FDA often learns of dangerous products and false or misleading submissions after many people have been harmed. The FDA seldom imposes any meaningful sanctions on makers of dangerous medical products; and may be limited in its power to stop the harm the FDA set in motion.
Buyer beware! The FDA does not protect us from dangerous medical devices! Dangerous medical devices can cause a lifetime of misery and regret. Industry also uses feigned FDA oversight as a sword against injured patients, citing regulatory oversight that barely exists as a defense, or approvals and clearances based on false and misleading industry submissions.
The FDA should refocus on its original mission of FOOD, DRUGS & COSMETICS. The public and medical community needs to be better informed as to what the FDA does NOT do. The FDA should also refocus its attention back to cosmetics, which are sorely in need of review, monitoring and warnings.
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