FDA Guidance Provides Relief for MDR Reporting During a Pandemic
Timely MDR reporting is a challenging regulatory requirement for the industry. A new FDA guidance provides much-needed relief during a pandemic.
FDA has just revised its relatively less known 2012 guidance entitled “Post-market Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” to clarify that the guidance is applicable to any pandemic, not just an influenza pandemic.
This is a smart action to help the medical industry during the current COVID-19 pandemic. Adverse event reporting requirements are very stringent, and late reporting of such events is a routine focus of FDA inspections and subsequent warning letters. This guidance provides relief to manufacturers, importers and user facilities, who may experience disruptions due to staffing issues in their operations.
While the guidance is applicable to all medical products and dietary supplements, including pharmaceuticals, biologics, blood and blood components, human tissue and tissue-based products and drug-device combination products, we will focus on relief for medical device adverse event reporting in this blog article.
It is important to note that organizations that are able to support normal operations during a pandemic are still expected to sustain the current reporting requirements. The guidance provides relief to only those organizations who may experience a disruption in their operations due to high absenteeism or other factors such as a significant increase in the frequency of adverse events related to a pandemic.
A summary of the guidance applicable to medical device reporting (MDR) during a pandemic is shown in the figure below.
In general, events requiring 5-day reporting and those involving patient deaths need to be submitted per current requirements even during a pandemic. Other nonfatal serious injuries and device malfunctions can be stored and delayed, if affected by operational challenges during a pandemic. However, FDA expects these stored reports to be submitted within 6 months of restoration of the adverse event reporting process to the pre-pandemic state.
Firms are advised to prepare a continuity of operations (COOP) plan to address potential challenges in maintaining the normal level of operations during a pandemic. FDA expects normal reporting of adverse events, to the extent possible, and as facilitated by the COOPs. When it is not possible to maintain these operations at their normal level, there should be criteria and requirements for documenting relevant factors such as high absenteeism or increased frequency of pandemic related adverse events. These plans should include notifying the FDA as needed, and guidelines for when the stored MDRs will be reported.
When FDA identifies certain products and issues that present special concerns during a pandemic, the agency may require compliance to normal reporting regardless of the general guidance provided for other types of MDRs.
Complaints handling is a challenging area for the industry and often requires a high level of resources for evaluation, reporting and follow-up investigations. Many companies have international operations, which require coordination among different centers and processing through a central complaints handling unit. During a pandemic, this can be particularly challenging to maintain at normal operating levels.
Compliance to MDR reporting requirements is a common area of deficiency for the industry. MDRs, late or not reported, are a frequent trigger for additional scrutiny during an inspection, which generally leads to discovery of deficiencies in MDR procedures. As shown in the graphic below, non-conformance to 21 CFR 803.17, requirements for developing, maintaining and implementing written MDR procedures, is among the top categories of observations in FDA warning letters.
As a result, timing of MDR reporting is a hot-button issue in the industry. It is not uncommon to see very stringent requirements in procedures as a follow up to internal audits or FDA inspections and warning letters. This guidance now provides an opportunity to plan and provide appropriate relief in your internal procedures. However, it is important to make sure MDRs stored and delayed during a pandemic, after appropriate justification, are promptly reported after the pandemic is over and operations are restored to the normal level.
In conclusion, this FDA guidance provides a much-needed relief during a pandemic to medical companies, importers and user facilities, such as hospitals, nursing homes and outpatient centers, from the strict MDR reporting requirements. MDRs related to nonfatal serious injuries and malfunctions, which normally must be submitted within 30 calendar days, may be stored and delayed until after the pandemic and restoration of pre-pandemic operational capacity. While the expectation is that those who can continue to operate at the normal levels during a pandemic must report MDRs within the required time frame, others who may have staffing or other issues could delay reporting of certain MDRs. It is a good idea to include these provisions in your procedures as part of your continuity of operations (COOP) plans.