Streamlining FDA Compliance with Digital Adverse Event Submissions

Santa Clara, Calif.-based Propel announces the introduction of Digital FDA Submissions, a product for medical device manufacturers subject to FDA reporting requirements. Propel’s Digital FDA Submissions allow medical device manufacturers to electronically create, submit, and track progress with MedWatch Form FDA 3500 submissions directly through the Propel platform. The new capability streamlines compliance with FDA 21 CFR Part 803 Medical Device Reporting and integrates all information exchanged with existing audit trails.

Companies can now complete a new Form FDA 3500 directly in Propel, leveraging product, customer, and quality information that already exists in the platform. Once completed, companies can submit the form electronically to the FDA through Propel, which records proof of submission. Propel then records all acknowledgments and other communications with the FDA as proof of reporting compliance.

Medical device manufacturers typically rely on manual systems, such as fax or postal mail, when submitting adverse events to the FDA. These methods, although the norm, is slower and less reliable in recording and time-stamping events accurately. Propel’s cloud-based quality management system helps Medtech organizations improve process efficiencies and audit readiness by submitting the MedWatch 3500A adverse event form electronically while tying and recording the proof of submission directly to the product record for future audits.

“Propel is fast to deploy, easy to use, and has the flexibility to support our processes in a single solution,” says Brent Lewis, director, Enterprise IT Quality and Compliance Systems at Advanced Sterilization Products. “Electronic adverse event reporting is the latest advance in Propel offering end-to-end capability connecting early design to customer feedback and regulatory reporting. This enables incredible insight intelligence and ensures compliance for our business.”

“With medical device manufacturers facing extreme competition in pursuit of higher quality, safety, and increasing customer demands for improved product features, it is critical to tie product, customer and quality data together,” adds Ray Hein, CEO of Propel. “Propel’s Digital FDA Submission capabilities help regulatory and quality teams easily and efficiently manage the entire process with FDA.”