A PMA application involves many volumes of material to be submitted to FDA. The volumes include device description and intended use, nonclinical and clinical studies, case report forms, manufacturing methods, labeling, etc. In the traditional PMA method, the complete PMA application is submitted to FDA at once. This method is generally used if the device has already undergone clinical testing and has been approved in a country with established medical device regulations. FDA has established methods of early collaboration with the sponsor allowing devices to brought to market as early as possible. These methods include the Modular PMA and the Product Development Protocol and are discussed below.
In a Modular PMA the complete contents of a PMA are broken down into well-delineated components (or module) and each component is submitted to FDA as soon as the applicant has completed the module, compiling a complete PMA over time. The PMA is viewed as a compilation of sections or "modules," such as preclinical, clinical, manufacturing, that together become a complete application. This method is recommended for products that are in early stages of clinical study. This method is not appropriate when the applicant is very close to being ready to submit a PMA or when the device design is in a state of flux or likely to change.
The process begins with a PMA Shell which lays out the plan for submission of the modules. The shell is an outline of modules and identifies information necessary to support the filing and approval of a specific Class III product through a combined IDE-PMA process. The review team will work with applicants to develop a customized shell for each specific product that includes module contents and suggested timelines. It is developed individually with the manufacturer for a specific device.
FDA reviews each module separately as soon as it is received allowing manufacturers to receive timely feedback during the review process. This may allow more rapid closure when the last components are submitted because much of the review work will have already been done.
Additional information on the Modular PMA process can be found in the following documents:
In the product development protocol (PDP) method for gaining marketing approval, the clinical evaluation of a device and the development of necessary information for marketing approval are merged into one regulatory mechanism. Ideal candidates for the PDP process are those devices in which the technology is well established in industry. The PDP process provides the manufacturer with the advantage of predictability once the agreement has been reached with FDA.
The PDP allows a sponsor to come to early agreement with FDA as to what would be done to demonstrate the safety and effectiveness of a new device. Early interaction in the development cycle of a device allows a sponsor to address the concerns of the FDA before expensive and time consuming resources are expended.
The PDP is essentially a contract that describes the agreed upon details of design and development activities, the outputs of these activites, and acceptance criteria for these outputs. It establishes reporting milestones that convey important information to the FDA as it is generated, where they can be reviewed and responded to in a timely manner. The sponsor would be able to execute their PDP at their own pace, keeping FDA informed of its progress with these milestone reports. A PDP that has been declared completed by FDA is considered to have an approved PMA (§814.19).
A Humanitarian Use Device (HUD) is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects or is manifested in not more than 8,000 individuals in the United States per year (Section 3052 of the 21st Century Cures Act (Pub. L. No. 114-255). For information on the Humanitarian Device Exemption (HDE) program and how to obtain approval of an HUD, refer to the Humanitarian Device Exemption webpage.
Additional Information On Humanitarian Use Devices
- Humanitarian Device Exemption
- Humanitarian Use Program Information
- Humanitarian Device Exemption (HDE) Regulation: Questions and Answers - Guidance for HDE Holders, Institutional Review Boards (IRBs), Clinical Investigators, and FDA Staff (PDF - 562KB)
- CDRH Learn HDE Modules (section on "How to Study and Market Your Device")