In 2006, the Center for Devices and Radiological Health (CDRH), a branch of the FDA, began examining the number of medical device reports they received. Over the past two years, the number of submitted reports has increased, sparking a demand for the CDRH to make a move to electronic reporting.
This week, the Advanced Medical Technology Association (AdvaMed) hosted the first of a three-part webinar series on electronic medical device reporting (eMDR) for adverse events. This initial question-and-answer webinar provided an overview of the eMDR system, the proposed regulation that was released to the public in August 2009 and the technical and business considerations that manufactures may have in choosing the low-volume approach or high-volume approach for report submission.
Due to the recent increase in report submissions, the CDRH wants to receive the reports more effectively, explained Debra Kacera, senior product manager of regulatory products at Pilgrim Software.
As it stands today, manufacturers must fill out MedWatch information, or the 3500A form. Once the FDA receives the information, contractors type in the data from the physical report into the manufacturer and user facilities device experience (MAUDE) database, making it available on the internet.
In addition to the CDRH seeking to receive reports in a more accurate and timely manner, the agency sought to eliminate human error for data entry and reduce non-value added costs associated with report submissions by bringing manufacturers on board with electronic data reporting, noted Kacera.
The first step in electronic reporting is generating the MedWatch data file and submitting it to the FDA electronic submission gateway (ESG), which Kacera said is the entry point for all electronic submissions and considered to be the first level of security.
Upon sending the electronic file to the FDA ESG, the FDA will ask for a digital certificate--a two-part electronic key--which defines the company as well as the submitter. Once the FDA verifies the certificate, they will issue an initial acknowledgement attachment, called Acknowledgement One, to the manufacturer to either the eSubmitter software (FDA software for low-volume submitters) or the gateway to gateway (commercial software including a B2B mechanism, for high-volume submitters).
The CDRH server is the second step for the manufacturers’ report. The file will be transmitted through the FDA ESG to the CDHR server were it will be validated and processed. After the completion of this step, the FDA ESG sends Acknowledgement Two to the submitter.
Pending validation from the ESG, the manufacturer will receive Acknowledgement Three, which will indicate either successful or failed submission into the adverse event database by the CDHR and make note of any errors that may have occurred during the validation and loading process.
It is recommended by the FDA that submitters save each of the three acknowledgments, which are stamped with the time and date of submission and approval, noted Kacera.
The aforementioned FDA eSubmitter software for low-volume submitters and commercial software for high-volume submitters are both choices for manufacturers for the building of their eMDR file.
“We expect that within the year, there will be a final rule which will only allow the electronic submissions of eMDRs, so one way or another, you are going to have to make a decision,” said Jeff Sacunda, vice president of technology and regulatory affairs at AdvaMed.
Kacera explained the decision process for manufacturers in coming to a resolution about what submission method to use. The first step involves manufacturers determining how they are going to build their MedWatch data and how will it be transformed into an eMDR file.
If the company does not have an existing complaint management software system, or if the application does not allow for the capturing of data to populate the MedWatch report, or does not generate the report itself, the eSubmitter software provided free by the FDA can be used to generate the company’s eMDR file, said Kacera.
If the application does have the capability to transform data into a complaint file, however, the company may upgrade to separate or commercial software, noted Kacera.
“[The software] all has to output to the exact same standard," stated Kacera. “It’s just a matter of which way you are actually going to build that file. It’s really dependant on what your company already has and what