A grandfathered device is a medical device that was sold to consumers before the FDA gained full regulatory authority of the medical device industry in 1976. When greater standards and regulations were put in place, these devices were classified and grandfathered into the system without further study or review into the devices' safety or efficacy.
The U.S. Food and Drug Administration (FDA)'s oversight of medical devices has come under scrutiny numerous times since the agency began actively regulating devices in the 1970s. The system designed to oversee the medical device industry and ensure quality standards has allowed many questionable devices to come to market, resulting in both patient injuries and consumer lawsuits. One frequently criticized loophole allowed thousands of grandfathered devices onto the market without any approval or review process at all.
History: FDA & Medical Devices
Though some facets of the FDA have existed since the turn of the twentieth century, the agency did not start regulating medical devices until the 1938 Federal Food, Drug, and Cosmetic Act was passed. Furthermore, device manufacturers were not required to register their products with the FDA or maintain any quality standards until the passing of the Medical Device Amendments of 1976.
This later piece of legislation introduced a three-tiered classification system for medical devices. These device classifications indicate both the risk of harm to a patient and the channel by which they are reviewed by the FDA. A Class III device, for example, carries the highest risk of harm for patients and therefore, undergoes the most scrutiny before receiving FDA approval.
The Creation of Grandfathered Devices
When the Medical Device Amendments of 1976 were enacted, thousands of devices were already available to consumers. While the new legislation created approval pathways for future devices, the FDA still had to review and classify those products on the market prior to the new laws. To avoid removing potentially life-saving medical devices from consumer use, the FDA grandfathered all medical devices marketed prior to the 1976 amendments into the system and temporarily classified the devices as medium-risk devices. This provisional measure was put in place until the agency could more thoroughly review the products and authorize additional testing if warranted.
Though the solution was meant to be temporary, it took the FDA several decades to review and reclassify the preamendment devices, during which time, these devices were sold to patients and consumers with little to no regulation or premarket clinical testing.
At the time the amendments were passed, the vast majority of preamendment devices grandfathered into the system were relatively harmless. However, the temporary measures left some high-risk devices - devices implanted or necessary to sustain life - on the market for decades without proper classification and no premarket approval testing generally required of high-risk devices.
How 510(k) Clearances Muddied the Water
This massive oversight has left its mark on the medical device approval process, influencing the approval for thousands of other devices that have come to market since 1976 thanks to the 510(k) submission process.
Following the Medical Device Amendments of 1976, devices with the highest risk of injury to a patient had two main pathways to gain access to the market through the FDA:
Premarket Approval Process (PMA) - Manufacturers were required to submit extensive scientific research and clinical trial data to prove that the device was both safe and effective in order to gain FDA approval.
510(k) Process - Manufacturers were required to submit information and scientific data proving only that the new device was substantially equivalent to an existing device (predicate device).
The PMA process was both rigorous and time-consuming, especially for the smaller FDA back in 1976. Conversely, the 510(k) premarket submission pathway was created to combat a long queue of devices waiting for approval. No clinical trials were required to prove the safety or efficacy of a 510(k) cleared device. A device reviewed by the 510(k) process is considered FDA-cleared, not FDA-approved, but the distinction between "approved" and "cleared" is largely unknown to consumers.
The Fatal Flaw of the 510(k) Clearance Process
The flaw in the 510(k) clearance pathway is that any device that is legally marketed can be used as a predicate device. In 1976, this meant that grandfathered devices could be used as predicate devices.
Even today, there are FDA-cleared devices that can trace their roots back to grandfathered devices that were never tested on humans. Some modern devices have received FDA-clearance because they are related to devices that were pulled from the market after causing a significant number of adverse events. Despite knowing the harm that this 510(k) system flaw has caused, in 2011, the FDA required just 1% of Class III devices to undergo the extensive and time-consuming PMA process.
Device Disaster Reality: Vaginal Mesh
In the late 1950s, surgical mesh became a popular device among surgeons for laparoscopic hernia repairs to reinforce the abdominal wall and reduce a patient's risk of recurrence. In the 1970s, gynecologists began to use the mesh to treat pelvic organ prolapse (POP). The 1970s also saw surgical mesh grandfathered into the FDA's new medical device classification system as a Class II or medium-risk device. By the 1990s, surgical mesh was being used in transvaginal repair to treat POP.
In the span of just a few decades and thanks to the 510(k) clearance process, transvaginal mesh was FDA-cleared and regularly used to treat a condition in a different part of the body and through a different means of surgery than its original predicate device, hernia mesh. Neither device went through clinical testing to prove safety or efficacy before entering the market.
In 2016, the FDA reclassified transvaginal mesh used to treat POP from a Class II device to a Class III device after reviewing countless adverse reports filed by women who experienced serious side effects from the mesh like infections, pelvic pain, organ perforation and mesh erosion. By April 2019, the FDA ordered the last companies selling transvaginal mesh to cease all further sales of the devices following thousands of adverse event reports and vaginal mesh lawsuits filed against the device manufacturers.
Be sure to check out our next post in the Device Disasters series next week! We'll be taking a closer look at the slippery slope that is daisy chain approvals and how flaws in the original 510(k) approval process have led to modern-day device tragedies.