Reporting adverse effects event as both a user facility AND a manufacturer (Part II)

Jul 2, 2015 | News

As we discussed in our last blog post, the FDA has put manufacturers of LDTs on notice that they must begin notifying the FDA if they are developing LDTs and begin reporting significant adverse effects, according to the draft guidance entitled FDA Notification and Medical Device Reporting for Laboratory Developed Tests (LDTs), the agency issued last October. FDA defines the term laboratory developed test (LDT) as an IVD that is intended for clinical use and designed, manufactured and used within a single laboratory.

Medical device reporting (21 CFR 803) is essentially the reporting of adverse events such as malfunctions, serious injuries, and death so the FDA can monitor their frequency and severity. User facilities must submit a report to the test manufacturer and the FDA within 10 days of becoming aware of the event; reports must be submitted within 30 days of learning of an adverse event by labs manufacturing LDTs.

Under the new guidance, all clinical laboratories manufacturing LDTs for clinical use are now required as medical device manufacturers to submit MDR reports to the FDA as follows:

  • Submit reports of individual adverse events no later than 30 calendar days after the day that the laboratory becomes aware of information from any source, that reasonably suggests that an LDT they manufacture:
    • May have caused or contributed to a death or serious injury or
    • Has malfunctioned and this device or similar LDT they manufacture would be likely to cause or contribute to a death or serious injury, if the malfunction were to recur (21 CFR 803.50(a))
  • Submit reports of individual adverse events no later than 5 working days after the day that the laboratory becomes aware of a reportable event that necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health; or a reportable event for which the FDA has made a written request. (21 CFR 803.53)
  • Submit supplemental reports within 1 month of the day the laboratory receives reportable information that was not submitted in an initial report. (21 CFR 803.56)

The only LDTs except from MDR reports are LDTs used solely for forensic (law enforcement) purposes and those used in CLIA-certified, high-complexity histocompatibility laboratories for transplantation.

Laboratories reporting on adverse events related to their LDTs must complete the MedWatch 3500A form available at
And then mail or electronically submit the form to the FDA.