HBM Prenscia

August 2017 – Points to Remember with Your FDA Premarket Approval

There are several points to remember with your FDA Premarket Approval for new medical devices. Devices that are Class III must receive the Food and Drug Administration’s (FDA) approval. This Class III approval, called Premarket Approval (PMA), is a license granted to the applicant to market devices that support or sustain human life, are of substantial importance in preventing impairment of human health, or presents a potential, unreasonable risk of illness or injury.

Due to the sensitive nature of these devices, the FDA requires a thorough development package to determine whether the appropriate design assurance, verification, and validation activities have been performed and that any present risk has been adequately assessed. Omnicon helps customers validate and document their software designs for Class III PMA submission. Below are some lessons learned from our extensive experience.

  1. Start the Device Hazard Analysis Early
    Many customers wait until after they have designed their hardware and software to perform a Device Hazard Analysis (DHA). Unfortunately, at that time, it is usually far too late to incorporate safety mitigations into the design. The only inputs required for a DHA are preliminary requirements and usage scenarios and the earlier you perform the DHA the easier it is to allow the DHA results to influence your design.


  2. Plan a Verification and Validation Campaign
    Class III devices come under great scrutiny regarding the thought put into validation. Testing is merely one method of validating a device, and is typically not enough by itself. Plan activities at every level of development of your device, including the unit level, integration level, and system level. Ensure your activities are guided by your requirements and Device Hazard Analysis.


  3. Control Everything
    From the start of your project, place all of your files, documents, and design artifacts under configuration control. This includes your entire development environment and any software or tools used to develop your product. Keep your Design History File up to date periodically, rather than trying to generate one at the end of the project. Use a requirements management tool to ensure every requirement is implemented, validated, and verified, and use defect tracking software to ensure all issues are documented and tracked to completion.


  4. Get an Independent Review
    Have an independent team that is unfamiliar with a product brought in to evaluate or challenge the work, take a look at your design and PMA package at various milestones so that issues and omissions can be uncovered early and prior to FDA submission. Use a checklist to ensure there are no omissions.


  5. Have a Plan for Commercial Off-The-Shelf Software
    Most modern products include some Commercial Off-The-Shelf (COTS) software or Software of Unknown Pedigree (SOUP). Plan the methods up front that will be used to analyze the hazards of using such software, and validate the software usage in your application. Don’t underestimate the work that may go into using COTS software simply because it is already written.The Omnicon Group establishes a clear and well-defined strategy to help you evaluate what documentation and additional documents or artifacts you will need to prepare and submit your Premarket Approval Application to the FDA. Find out more by visiting us at FDA-Premarket Services.

Tags: Class III, FDA, PMA Approval, Premarket Approval, validation



About Us

Omnicon provides custom engineering solutions for customers in aerospace, defense, transportation, medical and more.