The conventional approach of FDA for software-structured medical devices appears to be unfitting due to its certain limitations. Therefore, FDA proclaimed a pre-certification program recently which will foster new digital health solutions at the same time will give a lift to established medical device agencies.
This pre-certification program is basically a pilot program intended to pre-certify software originating market to foster the trend of quality in the development and analysis of the software. The actual purpose of this pre-certificate program is to swap the need for the pre-market compliance which was once a must for every medical device agency when introducing their products in the market. This program is also focused on the healthcare software providers that are usually not considered as medical device agencies.
After the examination period of this pilot program, it is anticipated that there will be good quality software firms who could easily establish digital health solutions accepted by FDA and at a faster pace. The industry of medical devices deeply apprehends the FDA regulations. A whole heap of the medical devices is now in use, comprising of software solutions bundled with smart hardware devices. These types of devices contribute a lot to the developing Internet of Things (IoT) in the healthcare industry. Due to the serious regulations on the manufacturing and administration of pre and post-market products, there are no or fewer options to modify or implement any product at a quicker pace.
This pre-certification program will contribute largely to taking customized moves for the regulation of this technology by examining and analyzing the software developer instead of inspecting the medical device first.
The pre-certification program intends to regulate the medical device agencies. This initiative took by FDA appeared very much useful to some large medical device companies since there was once unwillingness towards FDA regulations due to the lengthy processes specifications it involves. The unwillingness towards FDA regulation could put patients at higher risk due to the defenselessness of the medical devices towards cyber threats.
Key Features of the Pre-Cert Program:
FDA’s pre-cert program comes with the below-mentioned key features:
- Put an up to date and well-organized operation into practice fostering iterations in the software and occurrence of modifications in a fitting manner.
- Provide the medical device agencies with a hassle-free procedure to acquire and uphold precertification. In this way, the medical device agencies could easily keep up with the tailored processes set up for quality and excellence with negligible transformation for the regulatory reasons.
- Guarantees improve quality and in a similar way protected and pre-certified technologies would provide added security to users and to vendors as well. In this way, it provides an improved access to useful and secured digital health devices to the consumers.
- The flexibility to pace up with the advancement in the software development process and administration, the pre-authorization of useful healthcare technologies would sustain the overall system.
This pre-cert program has the tendency to restructure various digital health products possibly on hand for customers. FDA aims at lowering the regulatory pressure to aid in fostering the novelty of digital health devices. This pre-cert program by FDA holds a significant place in the medical and healthcare industry since it attempts to lower the load on the medical device agencies. Adding to it, this program is intended to deliver high-quality services to contribute to public health.
On the other hand, the criterion to pre-certify medical device agencies has not yet developed. At present, this program is in its initial phase and FDA is seeking input from stakeholder to produce a compact process.