Pre-Market Approval (PMA) is the name of the process the U.S. Food and Drug Administration (FDA) utilizes to review and evaluate the safety and effectiveness of medical devices which present a risk so great that ordinary regulatory controls are insufficient to guarantee their safety and effectiveness. PMA is the most stringent control the FDA has on medical device marketing, requiring applicants to supply copious amounts of valid scientific evidence prior to receiving approval from the agency.
Which Devices Are Required to Undergo PMA?
Medical devices are regulated by the FDA and can encompass a broad range of objects ranging from tongue depressors, to stethoscopes, lab equipment, surgical instruments and life supporting equiment such as ventilators. The FDA subjects “Class III” medical devices to PMA review. These are medical devices that support or sustain human life, or are substantially important for preventing impairment of human health, or themselves present a potential, unreasonable risk of illness of injury.
Agency approval of a PMA for a Class III device requires that the applicant establish a “reasonable assurance of safety and effectiveness” with scientific evidence. What this means is that the FDA will be looking for whether the device’s probable benefits outweigh its probable risks; while examining results of studies for effectiveness. The evidence the FDA examines during the PMA process typically includes:
- Studies and Trials
- Case Histories
- Reports of Significant Human Experience
History of Premarket Approval
The FDA began regulating medical devices following the enactment of the 1976 Medical Device Amendments to the federal Food, Drug and Cosmetic Act. Prior to that point, medical devices were not required to undergo any sort or federal oversight and inspection. Instead, they were regulated by a patchwork of state consumer protection laws applicable to all different types of consumer products.
The Medical Device Amendments created three classes of medical devices based upon their risk to patients. Class I devices are considered “low risk” (i.e. bandages and stethoscopes), Class II are “medium risk” (i.e. blood pressure cuffs, peripheral vascular catheters); and Class III “high risk”. Class I devices are generally exempt from FDA review, requiring only registration and adherence to basic FDA standards and practices. Class II devices can usually bypass the PMA process if they are deemed “substantially equivalent” to a preexisting device cleared for marketing. This process is known as the 510k pathway and does not require the rigorous testing that PMA demands. Generally speaking, all Class III devices are required to be reviewed under the PMA process, although a select few have been permitted to bypass PMA through the 510k process, something which has attracted substantial criticism in recent years.
How Does the PMA Process Work?
PMA review is a complex process that extends over multiple layers of review once the application process commences. First, the device manufacturer or patent holder must submit an application for PMA to the FDA. The agency will then conduct a “limited scientific review” of the application to determine if it is suitable for filing. Once the FDA is satisfied with the application package, it will clear the device for more thorough and in-depth review. Next the FDA will begin a thorough investigation of scientific and clinical data submitted by the applicant, as well as examine quality systems and regulatory compliance. Following this intense review stage, the FDA may subject its findings to an outside panel of experts called an “Advisory Committee”, which will hold public meetings and submit a final report to the FDA. Finally, the FDA will convene for final deliberations, documentations and then notify the applicant of its decision. The timeframe from start-to-finish for PMA review is typically anywhere between 240-350 days.
User Fees
A substantial component to the PMA process involves the user fees charged to manufacturers. The FDA collects user fees for the review of original PMAs and supplements. In recent years, the cost of an original device application was in excess of $250,000. These amounts are adjusted approximately every 5 years by Congress.
What Happens After a Device is Approved Through the PMA Process?
Once a device receives approval through PMA, manufacturers may make incremental changes to a device design without re-submitting it again. These changes are regarded as part of the normal “product life cycle” and the deference accorded to devices in this respect is very different from the process for drug approval where any change to the active ingredient would require a completely new FDA authorization.
When a device manufacturer decides to make changes or “supplement” an approved design, they can do so through varied review processes. The most substantive changes to a device design undergo a “panel track” supplement review where an independent panel of experts oversees the process and reviews newly collected scientific and clinical data to support the supplemental application. Other major changes, such as an improved design element may be approved within a 180-day window supported by limited “pre-clinical” data. Minor changes to correct any post-approval issues, such as battery life, may be handled by a “real-time” review conducted by the FDA without any need for additional clinical data.
Any change which does not alter the device itself, such as a change to a manufacturing process, only requires notice to the FDA. Changes to the device’s label to address newly discovered safety concerns can be made through a “special supplement” process wherein the manufacturer can make the change prior to formal approval by the FDA.
What Are the Legal Implications of the PMA Process?
When Congress handed oversight of medical devices to the FDA, it included language in the legislation which “preempts” legal claims against approved device manufacturers under state law (where most product liability claims arise). This application of the preemption doctrine was further refined in 2008 when the U.S. Supreme Court ruled in Riegel v. Medtronic that the PMA process specificially exempts approved manufacturers from state product liability tort claims.
It is worth noting however, that in the 1996 case Medtronc v. Lohr the Supreme Court did not extend the same preemption shielding to manufacturers who had bypassed the rigors of PMA, instead electing to seek approval under the 510k route. The court then reasoned that the “substantial equivalence” standard enumerated by the 510k process did not justify preeemption. Accordingly, only “high-risk” devices that run the PMA gauntlet are shielded from product liability claims.
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Tracy Everhart
Tracy Everhart is the Editor for Drug Law Journal. A highly-trained and certified medical professional, Tracy is also an accomplished medical writer. After spending years on the front lines of the medical profession, Tracy now devotes her expertise and skills to researching and reporting on new drugs and devices that enter the market, as well as their side-effects and the real-life stories involved. Prior to joining Drug Law Journal, Tracy wrote for benchmark online healthcare resources focused on families and, in particular, women’s health issues. Tracy holds post-graduate degrees from both the American College of Healthcare Sciences and the Yale School of Nursing. She is also a graduate of both Hampshire College, where she studied microbiology and the University of South Carolina school of nursing.