Premarket authorization (PMA) is a method by which the Food and Drug Administration reviews new medical devices and drugs. PMA is only allowed if the manufacturer can demonstrate safety and efficacy through “sufficient and well-controlled” studies conducted under harsh clinical conditions. Only then can the manufacturer start selling the product.
A pma submission is required for any medical device classified as Class III, which is intended to keep the patient alive or prevent an adverse event. It is surgically implanted in the patient’s body and can pose a certain amount of risk to the well-being of the patient. The pacemaker is the best known and commonly used class III device. Around 10% of all medical devices and products are included in the Class III category.
Unlike the 510 (k) processes, WFP is very strict, expensive, and time-consuming for the manufacturer. Some devices are exempt from PMA if they have a proven history of safety and efficacy and were on the market before 1976. Otherwise, the device in question must undergo a careful study under laboratory conditions.
The pma submission process is also expensive, particularly in the case of medical devices. On average, it can cost $ 94 million before a medical device can be marketed, and it can take a year or more. In contrast, going through route 510 (k) costs less than a third of that amount and takes half the time, which is why most manufacturers prefer to use that process whenever possible.
However, there is a clear advantage to completing the PMA process. The U.S. Food and Drug Administration (FDA) issued two final orders for manufacturers and the citizens to meet the requirements for surgical meshes used in the correction of pelvic organ prolapse (POP) transvaginally or through the vagina. The agency issued an order to reclassify these medical devices, class II. It generally includes moderate-risk devices to class III, which normally includes high-risk devices. And a second-order that requires manufacturers to request marketing approval (PMA) in support of the safety and efficacy of surgical meshes for the transvaginal correction of POP.
Orders require manufacturers to address safety concerns, such as severe pelvic pain and organ perforation and demonstrate safety and effectiveness through a rigorous PMA pathway. The measures concern only to mesh devices marketed for transvaginal correction of pelvic organ prolapse or POP. These orders do not apply to surgical meshes used with other indications, such as stress urinary incontinence (SUI) or abdominal POP correction.
Submitting an Application –
The process begins when the manufacturer submits a detailed request to the FDA. The agency describes this as a scientific and regulatory document to show the safety and effectiveness of the device to the FDA. The application should also provide details on how to design and manufacture the device.
The premarketing application includes the following sections:
- Technical information. It contains data and other information that informs the agency’s decision to approve the request.
- Nonclinical laboratory studies. It provides information on microbiology, immunology, biocompatibility, stress, wear, longevity, and other laboratory or animal experiments. FDA will guide manufacturers on how to conduct these appropriate studies.
- Clinical research. Details of how the study was conducted, data on device safety and efficacy, adverse reactions and complications, device failure, and replacement. This section also includes information about the patient, such as complaints, data aggregation for all individual subjects, and statistical analysis results.
The FDA also needs information on device labelling. During the initial review phase, FDA may ask the manufacturer for detailed information accompanying the application. If the information is not provided within the set period, the request is considered withdrawn, and the process must be restarted if the company wishes to move forward.
