PREMARKET APPROVAL (PMA)

Premarket Approval (PMA) is the FDA’s process of reviewing the safety and effectiveness of Class III medical devices. Class III devices support or sustain human life. Class III devices require Premarket Approval before they can be marketed in the US—an approved PMA is essentially a license granting the applicant permission to market the medical device.[1] The federal regulation governing PMA is Title 21 Code of Federal Regulations Part 814, Premarket Approval of Medical Devices.

PMA APPLICATION  

A PMA must include the following elements (unless an omission is justified by the applicant):[2]

  • Name and address of the applicant
  • Table of contents that specifies the volume and page number for each item in the table
  • Summary section containing information on indications for use, a device description, alternative practices and procedures, marketing history, summary of studies, and conclusions drawn from studies
  • A complete description of the device (including pictures and diagrams), each of the ingredients of the device, the properties of the device (relative to the diagnosis, treatment, prevention, cure, or mitigation of a disease or condition), the principals of operation for the device, and the methods, facilities, and controls used to manufacture, process, pack, store, and (if applicable) install the device
  • Reference to any performance standard or voluntary standard
  • Technical sections containing data and information, enabling the FDA to determine whether to approve or deny the application (technical sections should pertain to the results of nonclinical laboratory studies and the results of clinical investigations involving human subjects)
  • If a PMA is solely based on data from one investigator, applicants must justify and show that data and other information from a single investigator is sufficient to demonstrate the safety and effectiveness of the device
  • A bibliography of all published reports (not already submitted under §814.20(b)(6))—whether adverse or supportive—that pertain to the safety or effectiveness of the device
  • One or more samples of the device and its components (if requested by the agency)
  • Copies of all proposed labeling for the device
  • An environmental assessment in accordance with 21 CFR 25 must be included in the PMA application
  • A financial certification or disclosure statement (or both, as required by 21 CFR 54)
  • Any other information requested by the FDA.

The following document provides a PMA Review checklist: Acceptance and Filing Reviews for Premarket Approval Applications (PMAs) – Guidance for Industry and Food and Drug Administration Staff.

PMA REVIEW PROCESS

The review of a Premarket Approval application is a four-step process that include: [3]

  • Administrative and limited scientific review by FDA staff to determine completeness (acceptance and filing reviews)
  • In-depth scientific, regulatory, and Quality System review by appropriate FDA personnel (substantive review)
  • Review and recommendation by the appropriate advisory committee (panel review)
  • Final deliberations, documentation, and notification of the FDA decision.

During the administrative and limited scientific review stage, the FDA determines whether or not a PMA is suitable for filing. When an application is filed, it means that the FDA has determined that the application is “sufficiently complete to begin an in-depth review.” Within 45 days of a PMA being sent to the FDA, the agency will notify the applicant as to whether their application has been filed. The 180-day period for PMA review starts on the date of filing. [4]

Steps in the PMA application process include: [5]

  • Filing review
  • Statistical review for filing
  • Review of manufacturing information for compliance with the Quality System regulation (21 CFR 820).
  • PMA filing decision
  • Day-100 Meeting
  • Quality System Inspection(s) by the FDA field personnel
  • Bioresearch Monitoring Audit (audit of clinical study data)
  • Substantive review coordination and completion in areas such as non-clinical studies.

The procedure for “Day-100 Meetings” can be found in the guidance document “Guidance on PMA Interactive Procedures for Day-100 Meetings and Subsequent Deficiencies - for Use by CDRH and Industry; Final.”

The following document provides guidance on “PMA Acceptance and Filing Review Policy.”

 

Updated by Kevine Lidoro, November 2020