Devicemakers should submit new electronic Medical Device Reports several days before the deadline or risk being considered late under U.S. FDA requirements that take effect Aug. 14.
The extra time is necessary because the date of receipt will depend on the FDA telling the firm that the form was successfully loaded into the Center for Devices and Radiological Health’s database, says Deborah Kacera, a regulatory and industry strategist with Pilgrim Solutions.
The new system requires three electronic acknowledgements. The first contains the regulatory date that the FDA received the eMDR and lets the sender know if the form was received on time. The second informs the sender that the report passed through the electronic gateway and is on its way to the CDRH server, and the third tells the sender that the file has been accepted.
“If acknowledgement three comes back and says the submission failed, it will tell you what failed,” Kacera says. The sender must correct the failure, which may include a format or code issue, and resubmit the eMDR, restarting the process and requiring three new acknowledgements, she adds. Once approved, the file moves to the Manufacturer and User Facility Device Experience, or MAUDE, database.
Kacera, who spoke in a recent FDAnews webinar, also reviewed the steps devicemakers must take before posting an eMDR. The first is to generate an electronic file and send it to the FDA’s electronic submission gateway.
Next, companies need to submit a Non-Repudiation Letter affirming that the signer’s digital signature is equivalent to a handwritten signature. U.S. agents or consultants sending eMDRs for customers will need an authorization letter in addition to the Non-Repudiation Letter, Kacera says. A digital certificate that defines the sender as the company’s submitter must be sent to the FDA as well.
To assist companies, the FDA has free downloadable software that generates an eMDR file, she notes. When the required documents and software are in place, firms must do basic connectivity tests with the ESG. The agency will provide tests so that devicemakers can track submissions through the process to the MAUDE database.
Kacera recommends that during testing, companies create a “mock go-live” and attempt to submit eMDRs. Find it out ahead of time if the eMDR was done properly, she says, “because once you’ve gone live, you can’t go back.” — Charlotte Astor