FDA Pre-Cert

FDA PRE-CERT

Leading Security Through The life sciences Realm, The FDA is Constantly Working To Stay Aligned With Technology Trends and Upcoming Threats.

The FDA Pre-Certification Program

The FDA Pre-Certification program is designed to build a streamlined regulatory process around software as a medical device (SaMD).

While this program is currently in the pilot phase, the potential advances are ones we are ready to tackle at Digital Forge. The intent of the program is the assure future regulated Software based medical devices are held to the same standards are other medical equipment through verification of performance assurance and overall safety and program effectiveness.

With an interactive approach to a total product lifecycle the FDA is adapting to the speed at which technology progresses and changes. This program is intended to grow to continuous oversight on how products are developed. From concept to delivery, assurance is key to success with the FDA Pre-Cert program.

Help Align Your Organization To Apply and get Approval For The FDA Pre-Cert Program

Organizations or products with low risk can go through pre-certification and begin market introductions before final acceptance and general FDA review and approval. This program will not slow the to-market timeline for a product, it will dramatically decrease the timeline to begin public marketing options. When the FDA has confidence that an industry is low risk for delays, detrimental results or failed approval at testing and production stages, the pre-certification to proceed to marketing is granted.

Digital Forge is here to help align your organization to apply and get approval for the FDA Pre-Cert program when available. Though this is in pilot testing, we want to keep you informed and prepared to use this program if it fits for your software-based medical device development. This program will work with special elements and modifications to existing devices that are demonstrating improvements and meet Excellent Appraisal elements. Data received through the 501(k) program can be used to fulfill the pre-cert requirements.

For more information on the September 2020 FDA Pre-Cert updates follow the LINK.

As the pilot program progresses through testing and iterations, we will keep you informed when shifted to beta testing and eventually a functioning program.