Premarket Approval(PMA) for Medical Devices : Data Requirements
A Premarket Approval (PMA) application is a scientific and legal document submitted to the FDA to support the class III device’s safety and efficacy. A PMA application has administrative components, but sound research and scientific writing is key to a PMA application’s approval.
The goal of a pre-market approval (PMA) is to provide FDA with scientific and regulatory data that demonstrates the safety and effectiveness of a Class III device. Class III devices are defined by the FDA as “devices that support or sustain human life, are significantly crucial in preventing human health damage, or constitute a potential, unreasonable risk of illness or harm.” Therefore, these devices also require PMA in order to acquire marketing authorization in addition to the General and Special restrictions.
FDA will decline to accept a PMA application and won’t continue with the in-depth analysis of scientific and clinical data if a PMA application is missing any of the components listed in the administrative checklist.
A PMA application will take longer to analyze and approve by the FDA if it lacks reliable clinical data and solid scientific analysis. The approval or refusal of PMA applications has been delayed because of incomplete, inaccurate, inconsistent, inconsistent, and poorly organized PMA applications.
Technical Sections: The facts and information in the technical sections should be able to help the FDA decide whether to accept or reject the application. Clinical investigations and non-clinical laboratory research comprise the majority of these sections.
Non-clinical Laboratory Studies’ Section: Information on microbiology, toxicity, immunology, biocompatibility, stress, wear, shelf life, and other laboratory or animal tests can be found in the section on non-clinical laboratory research.
Clinical Investigations’ Section: Study protocols, protection, and effectiveness data, adverse reactions and complications, device failures and replacements, patient information, patient complaints, tabulations of data from all individual subjects, results of statistical analyses, and any other information from the clinical investigations are all included in the section on clinical investigations. Any inquiry carried out with the use of an IDE (Investigational Device Exemption )must be clearly labeled as such.
Although it typically takes longer, the FDA stipulates a processing time of 180 days for PMAs. During this time, the FDA examines the evidence, consults with the relevant FDA committee, and then decides. The FDA publishes the information used to make the decision on the Internet after notifying the applicant of the outcome, whether the PMA was approved or denied, and provides a 30-day window for requesting a reconsideration of the choice.
