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Premarket Approval Application Content Shell

A PMA can be viewed as a compilation of sections and "modules" that together become a complete application. The "PMA Shell" is an outline of those Sections that will be necessary to complete the PMA. It will include all modules needed to support filing and approval of a specific medical device. The term "module" will be used to identify a set of elements, tests, information, etc., addressing a selected aspect of the device subject to a PMA. A module may begin as the simple identification of the issue to be addressed and later developed into a detailed listing of the specific test results to be submitted as one report. What is needed for each module will be decided by agreement between FDA and the module submitter. Discussion and agreement are needed because modules will be accepted and reviewed individually as stand alone reports when they are received and the integrated review of the PMA will usually be based upon the review of each module taken together at completion rather than a review of the whole PMA as submitted. Ideally, the shell will be constructed in discussions held during the early stages of the investigational process. Alternatively, the shell might be constructed over time as the product is developed, constructed, and carried out by the module submitter.

Once a shell is established and the modular review process has been agreed to, a completed module may be submitted for review in a PMA Modular Submission (see PMA Implementation Procedures for a Modular Approach to PMA Review). As the information required for each module is reviewed and found acceptable by FDA staff, the shell is sequentially filled with these completed modules. At any meeting preceding the actual submission of the PMA, the module submitter and FDA can survey the shell to determine which modules have not been submitted and accepted. If the module submitter makes any design or technical changes to the device after the modules have been submitted, the module submitter should identify those changes and their effect in subsequent communications with FDA and submit supplement(s) to any relevant module. These supplement(s) should be identified with a description of the design and/or technical change(s), its effect, and identify the module information which has been changed.

When the reviewing division has determined that a module is complete and acceptable, a meeting with the ODE director or designee, an appropriate member of the Program Operations Staff (POS), and appropriate division staff should be held prior to issuing a status letter. Once closed (that is declared acceptable), a module will usually only be reopened for further review when the division director and ODE Director conclude there is strong rationale to do so.

Modules will contain various types of information ranging from pictorial representations of the device to clinical study data. The content and format of each element of a module will be specific to the information being conveyed. For example, the device description section and module may include engineering drawings and a description of each of the functional components or ingredients of the device. Module elements covering device testing (e.g., bench or clinical) may include: a description of the device or component tested and how it compares to the final device design proposed for marketing; the rationale or purpose of the testing; protocols describing the conduct of the test; test reports containing raw data (if required), a summary of the results (e.g., tabular format), and analyses of the results; and conclusions drawn from the testing.

Since modules may be submitted at various times throughout the development and review process, it is essential that each module also contain an easily identifiable "executive" summary describing the content of the submission and conclusions drawn from the data. These summaries will serve the dual purposes of providing an overview summary of the submitted module and, when assembled at the time of the PMA submission, will form the draft Summary of Safety and Effectiveness Data (SSED) for the device. The module submitter should keep in mind that the information provide in the modules should follow the content requirements listed in 21 CFR 814.20, as applicable.

Deficiencies identified during review of a module will be communicated to the module submitter in real time and documented in the file. Responses will be reviewed upon receipt. The agency intends to interact with the module submitter in a timely way with resolution of agency questions and deficiencies within 90 FDA days of receipt. When the review team finds that the issues in a module are resolved, a memo regarding the acceptance of the module will be added to the file and a status letter to the module submitter will be issued declaring the module to be closed. These review memos can be compiled at a later date to serve as the complete review documentation and memorandum for the PMA. A running list of open and closed modules will be maintained.

The elements of a PMA are grouped under the following 12 section headings. Each section may consist of one or more modules. The content of each module is dependent upon the specific device and will be determined by discussions between the FDA review team and the module submitter.