User Facility MDR Inspections: Emerging Signal of an FDA Compliance Concern?

January 13, 2016

By Melisa M. Moonan –

It has come to our attention that FDA has initiated inspections at several hospitals in various parts of the country to assess compliance with User Facility Medical Device Reporting (MDR) obligations under section 519 of the Federal Food, Drug, and Cosmetic Act (the Act) and 21 C.F.R. Part 803.

User Facilities such as hospitals are no doubt familiar with handling inspections by State licensing agencies and standards organizations, or even by FDA in the clinical research context. However, an FDA inspection related to MDR requirements may not be as familiar.

Although investigators conducting the inspections are referring to their work – which they candidly admit is a new effort for FDA – as “surveys,” these inspections have all the hallmarks and consequences of regular FDA inspections. Hospital-type user facilities have previously been the subject of warning letters for failures to report and a lack of the systems and procedures required by Part 803.

With all the recent inspections, we thought it would be a good time to post a reminder of User Facility MDR requirements and provide some thoughts on compliance.

User Facility Reporting and Record Keeping Requirements

In the 1990 Safe Medical Devices Act, Congress instituted User Facility reporting requirements for serious injuries and deaths under section 519 of the Act, and FDA subsequently promulgated related regulations under 21 C.F.R. Part 803.

Under the statute and regulations, User Facilities have 10 work days to report deaths and serious injuries when they become aware of information that reasonably suggests that a medical device has or may have caused or contributed to the event. Deaths must be reported to FDA and (if known) the manufacturer of the device.  Serious injuries must be reported to the manufacturer, or if the manufacturer is unknown, to FDA. In addition, annual reports attaching or summarizing the reports for the previous year must be submitted by January 1st.

User Facilities must also establish “MDR event files” and maintain them at least two years after the date of the event, § 803.18(c). The event files must contain information specified by regulation.  User Facilities must also have written procedures that require compliance with the relevant statutory and regulatory provisions.

The statute and regulations also authorize FDA to enter User Facilities at reasonable times to obtain access to, verify, and copy records that are required to be kept pursuant to MDR reporting obligations, and it is violation of the Act to 1) fail to make required reports, 2) fail to keep required records, or 3) refuse to permit an authorized FDA inspection.

As you can see, User Facilities need to have and maintain systems and procedures to ensure timely reporting and complete recordkeeping, and that provide for related FDA access. In this environment, it may be a good time for hospitals to review MDR systems and procedures for compliance, and ensure readiness for an FDA inspection.

Finally, the timing of the recent inspections is fairly coincident with other developments, including FDA’s new draft guidance on Public Notification of Emerging Postmarket Medical Device Signals (“Emerging Signals”) (Dec. 21, 2015) (see our previous post here). The inspections may indicate a concern that FDA needs to be more proactive to help ensure a level of User Facility MDR submission that is commensurate with incidence of reportable events, and which would enhance “Emerging Signals” detection and analysis. 

These developments suggest we can expect to see continued or even escalating agency activity in this area. User Facilities should consider getting ahead of the curve and proactively making sure that they are in compliance and prepared for inspection.

Categories: Medical Devices