It is the mandate used by the U.S. Food and Drug Administration (FDA) to guide how it regulates medical devices.
Sounds good doesn’t it? Of course patients expect the watchdog agency to be protecting the public health and safety by approving only the safest, most effective medical devices that are the least burdensome on American’s health and welfare.
Unfortunately that assumption is dead wrong.
As if we didn’t have enough proof of government working at the behest of corporations, least burdensome is regulatory language that imposes the least burden on industry!
Blame the rosy promises of “innovation,” made by device manufacturers hoping to turn enormous profits with very little regulatory oversight.
How did we get here?
Until 1975, the U.S. Food and Drug Administration (FDA) did not have the authority to regulate medical devices.
Only drugs had to prove their safety and effectiveness.
The push for regulation came from Congress after the Dalkon Shield IUDand other contraceptive intrauterine devices made front page news and countless numbers of American women were harmed.
Around this same time, there were thousands of medical devices already being sold that were increasingly complicated and implantable.
More stringent regulation was required.
At first, devices had to undergo premarket approval (PMA), which is the most stringent submission to the FDA. It requires extensive testing, clinical trials, and valid scientific data.
So Congress developed an easier pathway to the marketplace.
The language says in order to have the FDA approve any medical device, data should be provided to establish its effectiveness, however, “The Secretary shall consider, in consultation with the applicant, the least burdensome appropriate means of evaluating device effectiveness that would have a reasonable likelihood of resulting in approval.” (Section 513 (a) (3) (D) (ii) ).
It goes on,…”the Secretary shall only request information that is necessary to making substantial equivalence determinations….the Secretary shall consider the least burdensome means of demonstrating substantial equivalence and request information accordingly.”
In other words, the FDA holds hands with industry to walk it through the approval process in the fastest way possible to get to the marketplace.
The FDA’s 510(k) provision became the “least burdensome” way to enter the market. It didn’t require costly clinical trials. All manufacturers had to do was name a “substantial equivalent” device already marketed, as a “predicate device,” even if the mechanism or material was different.
Approval could take place in about 90 days at a substantially reduced cost.
In 2005, the average cost for a 510(K) review was a fee of about $4,000, compared to a PMA fee of about $200,000, according to the Government Accountability Office (GAO).
A 510(k) fast track to the marketplace would generally happen within 90 days as compared to up to 295 days for a PMA submission.
Reduce review times and costs for new device manufacturers was the goal to keep manufacturer “stakeholders” happy. But at what cost to Americans?
In a 2011 review of medical device recalls by the National Research Center for Women & Families, the consumer group found more than two-third of the faulty devices that had caused death or serious harm went through the 510(k) clearance process.
The Institute of Medicine in its 2011 report, (here) called the 510(k) clearance “fatally flawed” and suggested it be abolished.
A poll done by Consumers Union found most Americans believe the safety of patients should be the FDA’s most important mission, not making life easier for medical device makers.
The consumer group reminds us that even a defective medical device can still serve as a “predicate” devices that others can name as a substantial equivalent.
The FDA currently does not even have the power to require a medical device maker to fix a defectively designed device.
By 2010, trying to improve the situation, the FDA 510(k) Working Group suggested clinical trials be added to more 510(k) reviews in order to enhance safety. The Working Group also wanted the FDA to have greater authority to require premarket inspections and post-market studies.
The largest lobbying group for medical devices AdvaMed opposed those changes.
AdvaMed (Advanced Medical Technology Association) concluded since so few high-risk devices were cleared through the 510(k) process, those changes weren’t needed and the reports of injuries were overblown, even though more than half of all device recalls (51%) from 2005 to 2010 were cleared through the 510(k).
As an example of the tail wagging the dog, the FDA is very cognizant it does not want to burden the very industry it regulates with cumbersome regulations.
We’ve seen too many examples of how this love-fest harms American consumers.
Transvaginal mesh is one that was cleared for market with the least burden on industry, as were metal-on-metal hips, cardiac electrodes, endoscopes, stents, power morcellators, and defibrillators, among others.
This is not the FDA most Americans envision. This is not the fearless watchdog that requires a medical device be proven safe and effective, as a priority over profits, no matter how inconvenient it may be for industry.
But Least Burdensome and the 510(k) provision is the greatest way to get “innovative” medical devices swiftly into commerce with as little oversight as possible.
Interviewer and journalist has been turning her writing talents to legal news since she was a whistle blower some 20 years ago. She won her case against News Corp alleging she was fired for attempting to report news distortion to the FCC. The verdict was later overturned on appeal. Since then she has written consumer and personal injury news for a variety of major personal injury law firms. In 2011, Akre created the only website (www.meshnewsdesk.com) dedicated to exposing the transvaginal mesh mess which continues to this day. She loves interviewing lawyers who are working in the public interest! email@example.com