As we all know, the FDA will first evaluate the potential risk of a medical device before it is launched in the USA. The evaluation is done through a risk-based classification process to ensure the device’s safety, quality, and efficacy. The low-risk Class I devices require only general controls, and the high-risk Class II devices are subject to special controls and require more Regulatory scrutiny and oversight. But, for the highest-risk Class III devices, the FDA uses the most stringent Regulatory control – the Premarket Approval Process. What is the PMA process, and how to submit a PMA application? Let’s understand briefly.
PMA Submission Process
The Class III medical devices are of the highest risk and are designed with cutting-edge technologies to address adverse health conditions. They may include devices such as cochlear implants, pacemakers, implanted prosthetics, or high-frequency ventilators. While compared to the other two classification types, Class III devices pose the most significant risks to patients. Often, Class III devices are first of their kind, and therefore there is no predicate to which one can demonstrate substantial equivalence. Though the Class II devices have the option of seeking an exemption from premarket notification requirements through a 510(k) application, that’s not the case with Class III devices without having an already established device model to refer. Therefore, unless the Class III device is shown to be substantially equivalent to a cleared device, the FDA requires a PMA submission.
The FDA has identified some Class III devices' key characteristics and expects a few things for PMA submission.
FDA’s Key Characteristics of Class III Medical Devices
- Devices supporting a person’s life
- Devices permanently implanted in the body
- Devices having substantial importance in preventing an impairment
- Devices that otherwise present an unreasonable level of risk and/or fatalities
PMA Submission Requirements
- A constructed table of contents and cover letter
- A concise but thorough abstract section summarizing all the major points and broadly describing the information contained throughout the PMA
- Section-wise separated published laboratory results of both clinical and non-clinical human subjects
- Mention the indications for use to briefly describe the disease the device will treat
- Straightforward device description
- References to all the Regulatory, voluntary, and self-imposed standards that should be addressed during design and manufacturing
- Description of any possible alternative practices or uses for the device
- The studies and marketing research conclusions
- Any relevant updates of the device, marketing plan, or production
Without a doubt, the PMA process is very crucial, and the Class III device manufacturers who are willing to market their products in the US market must ensure to address the above requirements for PMA submission. To simplify your PMA process and expedite the market entry process, consult a proven Regulatory expert like Freyr - who can assist you with data assembling and design requirements. Stay informed. Stay compliant.