CDRH has unveiled two pathways to facilitate electronic Medical Device Reporting. This will hopefully increase the volume of MDRs, which are underreported.
Small manufacturers who don’t anticipate making many MDRs can use a program called CDRH eSubmitter, or CeSub. To use it, they can download special software, which runs on a PC and allows users to submit one report at a time.
Large manufacturers, who may need to submit hundreds of reports per year, can use a batch submission protocol in accordance with the health informatics standard known as HL7. An information guide on HL7 can be obtained by emailing indira.konduri@fda.hhs.gov.
In either case, the manufacturer must register with the FDA Electronic Submissions Gateway.
– From MD&DI’s blog.
The Senate on May 9 passed the FDA Revitalization Act, which includes the new version of MDUFMA, 93-1. The bill is getting more coverage in the media for its drug-industry reforms, particularly concerning safety issues, as evidenced by the piece in today’s New York Times. But it has significant impact on the device industry, too.
The language in the Senate bill keeps intact the entire agreement negotiated between FDA and the device industry over user fees, performance goals, and such, according to an AdvaMed release.
It’s now up to the House to produce companion legislation. A timetable for that has not been made public.
– From MD&DI’s blog.
The Senate on May 8 shelved a controversial amendment that could have impeded the enaction of the bill that includes the new version of MDUFMA, the Los Angeles Times reports. The amendment has nothing to do with devices — it would have allowed drug reimportation, and its inclusion likely would have prompted President Bush to veto the whole thing. Whether drug reimportation would have been a good or bad thing is not our concern here. What’s important is that the move by the Senate means there is one less obstacle toward MDUFMA II becoming a reality.
- From MD&DI’s blog.
Medical device companies are fine with paying higher user fees as long as it leads to a more predictable, streamlined process, reports the Record of Hackensack, NJ. “Enactment will help ensure that the agency has the resources necessary to fully evaluate medical device and diagnostic innovations and provide patients with timely access to medical technologies that can improve and save lives,” a Becton Dickinson spokeswoman told the paper.
The April 30Â public meeting on MDUFMA II did not produce any news of significance, according to several who were there. The table is set for a smooth Congressional approval process for MDUFMA itself. However, since it is bundled with controversial drug-industry legislation, it will not be passed quietly.
– From MD&DI’s blog.
