What Labs Need to Know About Reporting Adverse Events to the FDA

Whether a lab uses FDA-approved equipment or offers a laboratory-developed test (LDT) as part of its menu, reporting adverse events is something that must be done. Understanding the process of, and implementing designated procedures for, reporting adverse events is important to avoid underreporting and remain compliant. This is especially true for labs that offer LDTs, as they will soon be required to report such events as part of Stage 1 of the U.S. Food and Drug Administration’s (FDA’s) recently finalized LDTs rule.

A backgrounder on adverse events reporting for laboratories

Laboratories fall under Medical Device Reporting (MDR) guidelines. Every year, there are more than two million reports of suspected medical device-associated deaths, serious injuries, and malfunctions made to the FDA.¹ 21 CFR Part 803 addresses the requirements for manufacturers, importers, and device user facilities to report certain adverse events and product problems to the FDA.²

Clinical laboratories are considered “device user facilities.” The Medical Device Reporting for User Facilities guidance is a document issued by the FDA that provides detailed information about reporting requirements, written procedures, and enforcement, as well as important definitions and answers to frequently asked questions. According to this guidance, user facilities must report a suspected medical device-related death to both the FDA and the manufacturer within 10 work days. Device-related serious injuries are reported within 10 work days to the manufacturer or directly to the FDA if the manufacturer is unknown.³

Although not required to report a device malfunction, a lab may voluntarily advise of product problems using the Form FDA 3500.⁴ Labs utilizing FDA-approved medical devices are already required to report adverse events when they become aware that a device has or may have caused or contributed to a serious injury or patient death. However, facilities that offer LDTs will also soon be required to report adverse events to the FDA under the agency’s LDTs final rule. Therefore, if offering an LDT, Julie Ballard, CLS, MLS (ASCP), principal of Carrot Clinical, says that now is a good time for labs to review existing policies and procedures concerning reporting adverse events to ensure compliance.

Ballard emphasizes that, for labs that do not already have an adverse event reporting process in place, it is critical to develop and implement such procedures to ensure compliance by the May 6, 2025, deadline for implementing Stage 1 of the final rule.

Key steps when developing MDR procedures

Here are Ballard’s key steps for labs to follow when developing an adverse events reporting process:

• • Define “reportable event” in the lab’s standard operating procedures (SOPs), including what such an event comprises and when awareness of that event begins.

• • Establish a process to receive, record, review, evaluate, and resolve complaints.

• • Implement a system to record, investigate, track, and report all adverse events related to LDTs to the FDA.

• • Ensure SOPs cover the entire process and include instructions on reporting adverse events to the FDA within the correct time frame of becoming aware of the event, based on FDA requirements.

• • Train relevant staff on the procedures for reporting adverse events and the importance of doing so promptly and according to the FDA’s guidelines.
  • Obtain an FDA Establishment Identifier (FEI) and set up an account with the FDA’s Electronic Submissions Gateway (ESG) for electronic submission of MDR (eMDR).^5,6,7

Common mistakes flagged by the FDA during adverse events reporting

What are the most common MDR issues, according to warning letters issued by the FDA? Darrin Carlson, RAC-Devices, PMP, founder and principal of QA/RA Solutions, says one frequent mistake is that complaints are not evaluated to determine if they represent a reportable event under 21 CFR Part 803. According to Carlson, inadequate complaint procedures were cited 747 times by the FDA during inspections between 2019 and 2023.

Another frequent FDA inspection observation is a lack of documented MDR procedures, with 355 citations related to this problem issued between 2019 and 2023, Carlson says.

Carlson adds that another big issue seen in warning letters is important terms not being clearly defined in complaint and reporting procedures or not being consistent with 21 CFR 803. He suggests all labs who must report adverse events define terms such as “become aware,” “caused or contributed,” “malfunction,” “reasonably suggest,” and “serious injury” in their SOPs, as these are critical to understanding whether a complaint should be reported to the FDA.

How labs can remain compliant with FDA MDR requirements

In addition to following the key steps she outlined for implementing an adverse event reporting process, Ballard stresses that providing comprehensive and ongoing MDR training and education to relevant staff is crucial, as is preparing the MDR infrastructure in advance of the May 2025 deadline for Stage 1 of the LDTs rule. She notes that this will help labs avoid underreporting and/or delayed reporting issues. Reporting adverse events in a timely manner is paramount to compliance and can only be achieved if the correct procedures are in place and staff know how to follow them.

Additionally, as adverse event reporting must be done electronically, obtaining the lab’s FEI and setting up its ESG account ahead of the May deadline is crucial to ensuring that everything is in order for eMDR filing if an adverse event needs to be reported.

Finally, familiarization with Form FDA 3500A, which is used for mandatory reporting, as well as the various codes required as part of the reporting process (such as LDT product codes, adverse event codes, etc.), is another way Ballard encourages laboratories to prepare for reporting adverse events by the May 6, 2025, implementation deadline.⁸

Reporting adverse events to the FDA does not have to be an unpleasant or anxiety-provoking experience for laboratories offering LDTs or utilizing FDA-approved instrumentation. Though it’s possible that recently filed legal challenges or other developments could delay or eliminate the final rule, the safest course of action is likely for labs to ensure compliance to the Stage 1 requirements, including those for MDR. Following Ballard’s six key steps to implementing an MDR system will help ensure labs are prepared to make such notifications as required and avoid the common mistakes Carlson describes.

References:

1. 1. https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems
   2. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CFRPart=803
   3. https://www.fda.gov/media/73972/download
   4. https://www.fda.gov/safety/medwatch-forms-fda-safety-reporting/instructions-completing-form-fda-3500
   5. https://www.fda.gov/medical-devices/how-study-and-market-your-device/device-registration-and-listing
   6. https://www.fda.gov/industry/electronic-submissions-gateway
   7. https://www.fda.gov/medical-devices/mandatory-reporting-requirements-manufacturers-importers-and-device-user-facilities/emdr-electronic-medical-device-reporting
   8. https://www.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting