PMA Supplements

Over the course of a product’s life cycle, the device may require certain changes. Before these changes can be made, a manufacturer must acquire a PMA (Premarket Approval) supplement. A PMA supplement is the submission required for a change regarding the safety or effectiveness of a device for which an applicant already has an existing PMA. Similar to PMA supplements, PMA amendments include all additional submissions to a PMA or PMA supplement prior to approval of the PMA, PMA Supplement, or all additional correspondence after the PMA or PMA supplement.

The type of PMA submission depends on a number of factors, the most common of which is the data needed to demonstrate the safety and effectiveness of changes. Despite this, there are many different changes that require a PMA supplement as well as a number of types of PMA supplements. This blog will explain the changes that trigger the need for a PMA supplement, as well as a few of the many types of PMA supplements.

After the FDA has approved a PMA, the applicant must submit an PMA supplement for review and approval before making the proposed changes. Changes for which an applicant must submit a PMA supplement are vast, including but not limited to:

• New indication for use of the device.
• Labeling changes.
• The use of a different facility for the manufacturing, processing, or packaging of the device.
• Changes in manufacturing methods or quality control procedures.
• Changes in sterilization procedures.
• Changes in packaging.
• Changes in performance or design specifications, circuits, components, principles of operation, or physical layout of the device.
• An extension of the expiration date of the device based on data obtained under new or revised testing protocols that have not been approved by the FDA. If the protocol has been previously approved by the FDA, a supplement is not needed but the change must still be reported to the FDA.

While there are many types of PMA supplements, the four most common are the PMA Panel-Track Supplement, PMA Supplement (180 Days), Real Time Supplements, and Special PMA Supplements. Panel-Track Supplements are specific to changes that request a significant change in design, performance, or usage of the device. To gain a panel-track supplement, substantial clinical data of assurance of safety and effectiveness is required. 180-day PMA supplements are required for changes relating to the safety and effectiveness of a device, as well as changes in the components, materials, design characteristics, specification, software, or labeling.

Real time supplements are needed when a minor change to a device, such as a change in its design, is requested and the FDA has granted a meeting or similar exchange to review the status of the supplement in real time. Special PMA supplements are required when any changes enhance the safety of a device or the safety in use of the device, or for certain labeling and manufacturing changes that enhance the safety of the device. Special PMA supplements can be placed into effect by the applicant prior to the receipt of a written FDA order approving the PMA supplement.

PMA supplements are critical in any highly-regulated industry. At Aerospace Unlimited, owned and operated by ASAP Semiconductor, we can help you source all types of FAA PMA supplements parts through our PMA supplement list and deliver them with some of the industry’s best lead times. We’re always available and ready to help you find all the parts and equipment you need, 24/7-365. For a quick and competitive quote, email us at sales@aerospaceunlimited.com or call us at +1-412-212-0606. Our team of dedicated account managers is standing by and will reach out to you in 15 minutes or less.

1. steven helmer
2. Posted on July 3, 2020
aerospace