The FDA’s Center for Device and Radiological Health (CDRH) has had a focused project team engaged in developing, educating, communicating and assisting medical device companies on how to submit Adverse Event reports (MedWatch 3500A) in an electronic format, now known as eMDR (electronic Medical Device Report). In 2005, Indira Konduri, eMDR Project Manager, solicited help from industry to move forward on the testing and confirmation of the eMDR requirements. The solution leveraged the Health Level 7 standards (HL7) and the outcome was an Individual Case Safety Record (ICSR version 1). Kudos to the eMDR team during this period when the FDA showed an incredible ability to “listen” to the voice of industry and displayed a willingness to engage in joint discussions on the best way to handle issues.
The first company began submitting eMDRs in August, 2007, and the number of submissions shot up appreciably in 2009, such that, 19% of the 198,406 MDRs submitted were actually eMDRs. As of February, 2010, at least 40 companies were using the FDA’s eSubmitter software and 11 companies were using their own software solutions to create the ICSR version 1 electronic file to submit eMDRs.
This has been a slow industry adoption process when you consider that CDRH was “ready for business” back in 2007. Many companies are just starting to get educated, and many, as of yet, do not have an internal plan in place to support eMDRs. However, the question needs to be asked, “How many medical device manufacturers really need to be approved to submit eMDRs?” If so few who are signed up are already equating to almost 20% of the volume, then perhaps we can look at the Pareto rule and shoot for certifying at least 20% of the industry for an 80% eMDR submission rate?
To support manufacturers with the various types of electronic reporting mandates that the FDA has for Food, Devices, Drugs, and Biologic centers, the FDA in 2008, awarded up to $2.5 billion to modernize information technology over 10 years. This contract is the cornerstone of the FDA’s Information Technology for the 21st Century, a program they internally call, ICT21, that supports their IT modernization plans (see Cornerstone of 21st century Bioinformatics Initiative).
The proposed rule to make eMDRs mandatory was submitted for industry comments in August, 2009, and that comment period closed last November. There were very few comments from industry and from sources inside CDRH. There was nothing submitted that could not be addressed. So we all waited for the day the Final Rule would appear. People inside the FDA had surmised that we would see something as soon as the first quarter of 2010 . . . and then something this summer . . . and now. . . when?
Interestingly, on that same day in August of 2009, the FDA Center for Drugs and Biologics also released a proposed rule for mandatory electronic post-market reporting. Currently the format for receiving these reports is not identical to the new CDRH format. Does this pose a problem as more companies are bringing on combination products and may eventually need to do electronic adverse event reporting to two FDA centers? Will the new ICSR version the center is working on harmonize all the centers so Industry has a single format for submitting to a single FDA submission portal?
- We know that the eMDR is part of the technology strategy that CDRH has on its radar screen to support real-time data gathering for faster signal detection, to mistake-proof the process and to reduce non-valued added costs.
- We know today the “authorization” process for manufacturers to submit eMDRs requires specific testing and manual verification and approval by CDRH’s eMDR team. When you consider the 60-plus companies certified, and the thousands of companies that need to be certified, it’s a bit scary to think of doing this process manually and meeting a specific mandated date.
- We know that the CDRH applications and databases were moved to their new data center. CDRH was the first center to be moved over and that created a lot of internal work for that group to be able to realize future improvements.
- We know that CDRH wants you to start submitting your MDRs electronically.
Will CDRH make their eMDR submission mandatory using the ICSR version 1 release, and if so, when and what’s the hold up? Will CDER and CBER make their Adverse Event reporting mandatory on their unique file structure, or will they wait for the possible version X? Will CDRH and CDER electronic mandatory submission come into effect on the same date? What happens when you are a combination product manufacturer and you have to submit to both CDRH and CDER for an Adverse Event? Will all the FDA centers be moved to the new data center before the mandatory dates to accommodate the influx of reporting volume?
There are still so many questions, and with the actual date a moving target, Industry is moving slow to adopt, which may be a good thing as the FDA is methodically moving forward putting all the bricks down for a solid foundation.