PMA dossier for the 3rd class medical devices.

One of the articles in the US medical device registration section was devoted to the PMA (premarketing approval) procedure. As part of this procedure, a dossier must be submitted to the FDA, consisting of two parts – administrative and technical. This article will consider the documents included in the dossier.

The dossier itself is called “Premarket approval application”. The applicant or an authorized representative shall sign the PMA.

PMA includes:

  • Information about applicant (name and address)
  • A table of contents that specifies the volume and page number for each item referred to in the table
  • A summary in sufficient detail that the reader may gain a general understanding of the data and information in the application. It usually contains:
  • Indications for use
  • Device description. An explanation of how the device functions, the significant physical and performance characteristics of the device. A brief description of the manufacturing process should be included.
  • Alternative practices and procedures. A description of existing alternative practices or procedures for diagnosing, treating, preventing, curing, or mitigating the disease or condition for which the device is intended.
  • A brief description of the foreign and U.S. marketing history, if any, of the device, including a list of all countries in which the device has been marketed and a list of all countries in which the device has been withdrawn from marketing for any reason related to the safety or effectiveness of the device.
  • Summary of nonclinical and clinical studies.
  • Conclusions drawn from the studies.
  • A complete description of the device, each of the functional components or ingredients of the device, the properties of the device relevant to the diagnosis, treatment, prevention, cure, or mitigation of a disease or condition, The principles of operation of the device, the methods used in, and the facilities and controls used for, the manufacture, processing, packing, storage, and, where appropriate, installation of the device
  • Reference to any performance standard
  • Section with results of nonclinical and clinical studies
  • For a PMA supported solely by data from one investigation, a justification showing that data and other information from a single investigator are sufficient.
  • A bibliography
  • Samples of MD
  • Copies of all proposed labeling for the device
  • An environmental assessment
  • A financial certification or disclosure statement or both
  • Information concerning uses in pediatric patients.
  • Such other information as FDA may request.