The Premarket Approval (PMA) Process 

What is a Premarket Approval (PMA)? 

Premarket Approval (PMA) is a regulatory review process used by the FDA to ensure the safety and effectiveness of Class III medical devices. Class III medical devices include those with the highest risk. They usually sustain or support life, are implanted, or present a potential risk of illness or injury. Due to their elevated risk, the FDA determined that the general guidelines alone are insufficient to assure their safety to the public. Therefore, these devices require a PMA submission to be approved for the market. 

What is the Difference between a PMA and 510(k) submission? 

Both premarket approvals and 510(k) are regulatory submissions made to the FDA for medical devices. A PMA is required for Class III devices, while Class II devices require a 510(k) submission before they can be legally marketed. With the increased risk of Class III devices, the PMA process is more rigorous and in- depth than that of a 510(k). The purpose of a PMA is to prove that devices in the most stringent category for medical devices are safe and effective for their intended users. While a 510(k) is used to provide the FDA with documented evidence that the medical device is substantially equivalent to a predicate device.  

The PMA Approval Process 

The PMA process starts when the medical device manufacturer submits an application to the FDA. It is important for this to be as detailed as possible, and strongly convey the safety and effectiveness of the device. The application should go into further detail on how the device was designed and manufactured. Required in the submission are sections for Technical Information, Non-Clinical Laboratory studies, and Clinical Investigations. The FDA also requires labeling information for the device. If your application is accepted, it goes through further substantial review by FDA personnel and additional information may be requested. PMA approval is based on a determination by the FDA that the application contains sufficient scientific evidence that proves that the device is safe and effective for its intended users.  

Regulatory Capabilities at Gilero 

If your device qualifies for a PMA submission, our well- experienced regulatory team can help you from any point in the approval process. Gilero can provide on-going consultation services throughout a product’s life cycle, or as new requirements are published by regulatory agencies. Our regulatory experts at Gilero can conduct regulatory assessments, define the appropriate regulatory pathway, and prepare all the necessary documents for your PMA submission.  

Some of Gilero’s Quality & Regulatory capabilities include: 

• 510(k), PMA (Pre-market approval), and DeNovo support 

• Technical files, for CE Marking in the EU 
• Investigational device exemption (IDE) 
• Pre-IND and IND (Investigational New Drug) for combination products
• NDA or ANDA (New Drug Application/Abbreviated New Drug Application) for combination products 
• Regulatory assessments 
• Medical device classification 
• US FDA strategy 
• EU and Canadian strategy 
• Selection of predicate device(s) 
• Determination of primary mode of action (PMOA) for combination products 
• Office of Combination Product (OCP) Request for Designation (RFD) 
• Identification of applicable consensus standards and guidance documents 
• Significant/non-significant risk designation for investigational devices 
• Investigational Review Board (IRB) documentation 
• Labeling content and layout design, including Instructions for Use (IFUs) 
• Clinical Evaluation Plans (CEP), Clinical Evaluation Reports (CER) 
• Postmarket Clinical Followup (PMCF), Postmarket Surveillance Report