When launching a new medical device to the market, manufacturers must comply with the strict regulations of the U.S. Food and Drug Administration (FDA). The two most common processes are PMA (Premarket Approval) and 510(k). In this article, GOL will explain what PMA is, compare it to 510(k), and help you understand the appropriate process for your device.

What is the Premarket Approval (PMA)?

Premarket Approval (PMA) is the FDA’s scientific and regulatory review process to evaluate the safety and effectiveness of Class III medical devices – devices that support or sustain human life and pose a high risk. Due to the level of risk and importance of Class III medical devices, the FDA has determined that general controls alone are not sufficient to ensure their safety and effectiveness. Therefore, these devices are required to undergo Premarket Approval (PMA) before they can be marketed.

Manufacturers of medical devices must obtain FDA approval for their PMA submissions before marketing their devices. FDA approval signifies that the PMA contains sufficient valid scientific evidence to ensure that the device is safe and effective for its intended use.

What’s the difference between a 510K vs PMA?

The 510(k) clearance signifies FDA authorization to market a moderately risky medical device, whereas PMA (premarket approval) is mandated for products deemed higher risk and more innovative. PMA submissions usually entail a lengthier process and demand additional evidence, such as clinical trial data, to establish the safety and efficacy of a device for its intended users.

The FDA classification of devices operates based on different classes

Class 1

Class 1 devices, like toothbrushes, usually do not necessitate FDA approval. However, manufacturers are required to self-certify by registering their company and device on the FDA website before commercializing them. This registration process typically spans between 30 to 90 days.

Class 2

Class 2 devices are considered to pose a higher risk compared to Class 1. The FDA defines them as “devices for which general controls are insufficient to provide reasonable assurance of the safety and effectiveness of the device.”

Examples of Class 2 devices include:

• Catheters
• Pregnancy tests
• Blood pressure cuffs
• Blood transfusion appliances
• Surgical gloves
• Contact lenses
• Syringes
• Absorbable sutures

To obtain authorization to market Class 2 medical devices, developers can opt for a 510(k) premarket notification rather than the more rigorous PMA (Premarket Approval) submission if equivalent devices are already on the market. While most Class 2 devices fall under this category, there are exceptions.

The 510(k) process entails submitting a comprehensive application to the FDA, demonstrating the device’s safety and effectiveness by establishing its “substantial equivalence” to a predicate device already available in the market. Submissions are made through the FDA website and require meticulous assembly and sharing of documentation in a structured manner. This documentation typically includes:

• Detailed device description
• Labeling information
• Discussion of substantial equivalence to the predicate device
• Supporting data from performance testing

Upon successful submission, the FDA will issue a 510(k) clearance letter and post it on their website. This website posting serves as official confirmation that the device has been cleared by the FDA, providing authorization for market entry.

Class 3

Class 3 devices are characterized as high-risk and often involve entirely novel technology. Due to the significant level of risk they pose to consumers, they necessitate full Premarket Approval (PMA) rather than mere authorization from the FDA.

Devices in this category are defined by regulations as those that “sustain or support life, are implanted, or present a potential unreasonable risk of illness or injury.” Only a small fraction, approximately 10%, of medical devices fall into the Class 3 category. Examples of Class 3 devices include:

• Pacemakers
• Breast implants
• Defibrillators
• Ventilators
• Fetal blood sampling monitors
• Implanted prosthetics

When is PMA required?

• The PMA process requirements apply to Class III medical devices, which are the most strictly regulated category for medical devices. (Businesses can learn how medical devices are classified by the FDA at the FDA medical device certifications). If unsure about the classification of a device or whether a PMA process is required, one can search the Premarket Approval (PMA) database and the 510(k) Premarket Notification database based on the product code.
• While most Class III devices are required to adhere to Premarket Approval (PMA), there are exceptions. These include Class III devices that were already on the market before 1976 or before the FDA was granted authority in this area.
• There may be instances where a new device is not found in the device classification database. In such cases, if the device is deemed high-risk (sustaining or supporting human life, of substantial importance in preventing impairment of human health, or presents a potential unreasonable risk of illness or injury), then it must have PMA approval before being marketed in the United States.

Who submits Premarket Approval (PMA) applications?

The PMA applicant is the owner, with access to the data and information submitted to support FDA approval. The applicant is typically the inventor/developer and manufacturer of the medical device.

What does a Premarket Approval (PMA) application include?

A Premarket Approval (PMA) application includes:

• Administrative checklist items.
• Documentation and scientific literature regarding the medical device.

If a PMA application lacks the elements listed in the administrative checklist, the FDA will reject the submission for PMA registration and will not proceed with in-depth review of the scientific and clinical data.

Furthermore, if a PMA application lacks valid clinical information and scientific analysis based on sound scientific reasoning, it may affect the FDA’s review and approval process.

• The application should also include technical information, along with relevant data and additional information to inform the decision-making body whether to approve the registration application or not.
• Non-clinical laboratory studies should be conducted to provide information on microbiology, immunology, biocompatibility, stress, wear, shelf life, and other tests in laboratories or other animal testing. The FDA provides guidance to manufacturers on how to conduct appropriate studies.
• Clinical investigations should detail how studies were conducted, data on the safety and efficacy of the device, any adverse reactions and complications, device failures, and replacements. This section also includes patient information, including complaints, data tables from all individual study subjects, and statistical analysis results.

Read more: FDA approved vs FDA cleared: The differences you need to know

How long does the FDA review PMA applications?

The FDA’s review of Premarket Approval (PMA) applications typically takes 6 months, but it can, and often does, take longer than that. During this process, device manufacturers are required to provide valid scientific evidence demonstrating the safety and efficacy of the device.

Read more: What is the frequency of medical device audits by the FDA?

Pros and Cons of PMA for Medical Device Manufacturers

Research on approvals for cardiac implantable electronic devices indicates that, on average, for every device approved through the Premarket Approval (PMA) process, as many as 50 devices are approved through supplemental processes.

Advantages of the PMA Process:

• Legal Protection for Manufacturers: If a device is approved through the PMA process, consumer lawsuits become significantly more challenging due to the legal standard of preemption, making it difficult for consumers to pursue legal action against the manufacturer. Conversely, devices approved through the 510(k) process are more susceptible to litigation.
• Competitive Advantage: For some financially capable manufacturers, successfully navigating the more rigorous PMA process can provide a competitive edge, compelling other companies to follow suit and potentially eliminating competitors from the market.

Disadvantages of the PMA Process:

• Time and Cost: Manufacturers often avoid the PMA process due to its lengthy duration and high costs. For instance, in 2013, the average time for PMA approval was 432 days.
• Scientific Evidence Requirements: Manufacturers are required to provide valid scientific evidence regarding the safety and efficacy of the device.

Above is some information about Premarket Approval (PMA) that GOL wants to share with you. If any businesses are in need of FDA certification for medical devices, please feel free to contact GOL for consultation and assistance.

References:

According to Joe Byrne – The FDA submission process: 510K vs PMA. What’s the difference? – Cognidox.

According to An official website of the United States government – U.S. Food & Drug Administration (FDA) – Premarket Approval (PMA).