Understanding The FDA Approval Process for Drugs and Medical Devices
We are surrounded. Billboards, full-page magazine ads, and even late night television are rife with advertisements for new and promising medical devices. Medical devices are big business, and the companies that produce these instruments devote tremendous research and resources to testing and research in an attempt to ensure their efficacy. In 2016, the industry, which is comprised of approximately 6,500 companies is expected to comprise a $130 billion market. Fortunately, for the most part the devices that companies bring to market are in fact useful, and in some cases, life saving. Consider the overwhelming success of pace makers and surgical plates and screws. The lesser-known reality about medical devices, however, is that in many circumstances the companies that produce the device are the only entity actually testing the devices before they are brought to market.
The United States Food and Drug Administration (“FDA”) is charged with protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation (1). While the FDA certainly performs yeoman’s work when it comes to protecting the public, many people are surprised to find out that the FDA does not actually test all the medical devices that come to market. This should not come as surprise given the tremendous volume of devices that come to market each year.
The FDA defines a medical device as “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is intended for use in the diagnosis or treatment of a disease or medical condition (2). Therefore, medical devices can range from a q-tip to a hip implant to an artificial heart.
If you have a company with a new medical device there are two primary to bring your device to the American market by way of the FDA. One process is called “Premarket Notification,” often called the “510(k) process.” The other is called Premarket Approval and is known by its submission acronym “PMA.” There is however, a radical difference between the two approval processes.
The 510(k) Fast Track
510(k) is a section of the Federal Food, Drug and Cosmetic Act which the FDA must follow. In that lawyers are not overwhelming creative, we decided to simply name the process after the Code Section. The 510(k) is a premarketing submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to premarket approval. It is essentially legally “piggy backing” a device on the back of a similar existing device. A company attempting to bring a device to market under the 510(k) process must submit a relatively simple filing to the FDA at least 90 days before marketing unless the device is exempt from 510(k) requirements.
It is not to say that this process is inexpensive, costing approximately $32 million, or that the process is not safe or thorough. It simply means that medical device manufactures and the FDA are capitalizing on the sound research that came before. Keep in mind though that the 510(k) process is not particularly high and does not constitute FDA approval of a device.
It is important to understand that simply because a device, such as metal on metal hip prostheses, is cleared by the FDA for marketing; it does not mean that they are safe. In fact the United States Supreme Court has said as much noting the 510(k) approval does not constitute an approval by the FDA as to the quality of a device. (3)
Finally, since the FDA wants to encourage technological advancement, and rightfully so, the new device does not have to be manufactured from the same materials or perform its intended purpose using the same technology. Rather the “old” device to which the new one is being compared must only be substantially similar. Due to the fact that this is the the path of least resistance for medical device clearance, almost 90% of all medical devices that come to market come via the 510(k) process. (4)
The Pre Market Approval Approach
Conversely, premarket Approval (PMA) is the most stringent type of device marketing application required by FDA. Only 10% of all medical devices come to market under this approach, and the process averages a staggering $90 million.
Further, the PMA process takes approximately seven years. A PMA is an application submitted to FDA to request approval to market. Unlike premarket notification, PMA approval is to be based on a determination by FDA that the PMA contains sufficient valid scientific evidence that provides reasonable assurance that the device is safe and effective for its intended use or uses. This is a far more rigorous process consisting essentially of four steps:
- administrative and limited scientific review by FDA staff to determine completeness (filing review);
- in-depth scientific, regulatory, and Quality System review by appropriate FDA personnel;
- review and recommendation by the appropriate advisory committee (panel review); and
- final deliberations, documentation, and notification of the FDA decision. (5)
The PMA process takes far more time, effort, and resources on the part of the manufacturer and consequently the 510(k) is used far more often by medical device companies. Under the PMA process, the FDA reviews the device on a completely new “de novo” basis. This means that prior designs, even if substantially similar, are not considered.
Despite the cost and time, this process is not without its benefits. Once a device earns the PMA approval from the FDA the device is considered safe, and in most cases any claims based on a design defect are considered preempted.
- Medtronic v. Lohr, 518 U.S. 470 (1996) (“. . . common law claims are not preempted by the Federal Labeling and Manufacturing Requirements).