FDA’s MedWatch System to Offer More Consumer-Friendly Reporting Form
The U.S. FDA will roll out a simplified adverse event reporting form this spring in hopes of getting more consumers to use its MedWatch system, agency officials said.
The agency also hopes to broaden use of its MedWatcher smartphone app, which allows quick submission of voluntary MDRs that may include photos, says Stephanie Joseph, a biomedical engineer in the FDA’s Office of Health & Constituent Affairs.
The new report forms, which become mandatory on July 1, add checkboxes allowing submitters to note the patient’s age in years, weeks, months and days, which may be helpful for reports involving infants, Joseph says. She spoke at a webinar hosted by the American Academy of Medical Instrumentation.
The 3500B consumer form is one of three debuted in a December Federal Register notice of upcoming changes to both paper and online versions of the forms. The others are the 3500 for healthcare providers and 3500A for devicemakers.
William Maloney, a physicist in the FDA’s device center, sought to clarify exemptions to mandatory MDR reporting. These include an alternative summary report — a periodic summary of all adverse events for devices that have been on the market for at least two years, a remedial action exemption for further reports of device failures collected while a recall is already underway, and the single MDR exemption, which allows for a single form to be submitted per incident if there are multiple mandatory reporters in play.
To request a single MDR exemption, devicemakers and importers should send an email to email@example.com briefly explaining the situation and including registration and listing information for the possible reporters. FDA staff will respond with advice, Maloney says.
Injuries should normally be reported via MDR if they require medical treatment, Maloney says. For example, a cut from a jagged edge of a device that required stitches would need to be reported, while a scrape would not. But the ultimate definition of “serious injury” is decided by the staff at the user facility, he says.
Devicemakers must take steps now to secure a production account for submitting electronic Medical Device Reports ahead of an Aug. 14, 2015 deadline for compliance. Need help making it on time? Get the Top 7 Keys to eMDR Success: The Deadline is Near, Are You Ready? webinar CD.