21 CFR Part 820, Device GMP Booklets - $5.50 Each with Vinyl Cover

Remember the good old days of "obligation" medical device reporting? Well, those days are officially over. Under the requirements of FDA's Medical Device Reporting (MDR) Final Rule, which took effect on July 31, 1996, MDR might as well stand for mandatory; and in addition to establishing stricter reporting requirements, the expanded regulations affect a much broader group of user facilities.

According to FDA, the failure of manufacturers, distributors, and user facilities to comply with Section 519 of the Safe Medical Devices Act spurred a need for change to protect the public. In 1986, the General Accounting Office (GAO) reported that less than 1 percent of device problems occurring in hospitals were reported, a statistic that helps account for Congress' and FDA's frustration with previous "obligation" reporting. Despite its recent changes, the MDR compliance program is not a unique article of legislation - Congress patterned the program after the National Traffic and Motor Vehicle Safety Act of 1966, the Radiation Control for Health and Safety Act of 1968, and the Consumer Product Safety Act of 1972.

Note: The requirements for malfunction reporting as described in the following paragraph have been clarified at the suggestion of several readers. Amendments to the previous phraseology are indicated in bold. To those readers who responded, your comments are appreciated.

FDA's requirements for the MDR are simple: when you become aware of a specified device malfunction, report it using the authorized form. For manufacturers, malfunction reporting is necessary when there is a chance that (1) death or serious injury was caused, in whole or part, by the device; (2) a malfunction has occurred that could cause or contribute to death or serious injury if it recurred; (3) the "consequences of the malfunction affect the device in a catastrophic manner that may lead to a death or serious injury"; or (4) the malfunction results in failure of the device to perform its essential function and compromises the device's therapeutic, monitoring or diagnostic effectiveness which could cause or contribute to a death or serious injury, or other significant adverse device experiences required by regulation (the Final Rule points out that "the essential function of a device refers not only to the device's labeled use, but for any use widely prescribed within the practice of medicine"). A malfunction is not reportable if it can be corrected during routine service/maintenance, unless as noted, recurrence would be likely to cause or contribute to death or serious injury. All reports by manufacturers must be submitted directly to the FDA.

For user facilities, information from any source that reasonably suggests that a device has or may have "caused or contributed" to the death or serious injury of a patient or employee of the facility indicates a reportable event. (The new regulations define "caused and contributed" to mean "that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in death or serious injury.") Deaths must be reported directly to the FDA and the manufacturer. Serious injuries must be reported directly to the manufacturer, or to FDA if the manufacturer is unknown.

As noted earlier, the types of regulated facilities have increased. Hospitals, nursing homes, home health agencies, ambulatory surgical facilities, ambulance providers, rescue squads, rehabilitation facilities, and all outpatient treatment and diagnostic facilities that are not physician's offices (of similar healthcare practitioners' offices, such as dentists, chiropractors, etc.) must comply with the new regulations.

Distributors (whose reporting requirements currently are covered under 21 CFR 804.25) are required to report information from any source that reasonably suggests that there is a probability that a device marketed by the distributor has (1) caused or contributed to a death or serious injury; or (2) has malfunctioned and such information reasonably suggests that there is a probability that such a device or any other device marketed by the distributed would cause a death, serious injury, or serious illness if the malfunction were likely to occur. The Agency intends to change the distributor reporting requirements to confirm with those for manufacturers and user facilities in the Final Rule. Under the current regulations, distributors must report deaths and/or serious injuries directly to FDA, with copies to the manufacturer, and submit reportable malfunctions directly to the manufacturer.

All three types of reporting parties (manufacturers, distributors and user facilities) have been given different time requirements to report. The user facility is required to report a death or serious injury to the manufacturer within 10 days, and a report to FDA within 10 days if death occurs. The distributor must report to the manufacturer and FDA within 10 days for all reportable events. The manufacturer must report all events to the FDA within 30 days. Reportable events requiring remedial action to prevent an unreasonable risk of substantial harm must be reported within 5 "working" days.

Now are you confused? Confusion could become synonymous with the new requirements. Whether you are a manufacturer, distributor or user, a good practice is to start the report process immediately when a malfunction is encountered. Upon becoming aware of a legitimate device malfunction, complete FDA Form 3500A, unless this is your first report for that particular device. First-time reporting requires an FDA Form 3417 Baseline Report and FDA Form 3500A. Form 3500A requires use of the FDA's Mandatory Reporting Form Coding Manual, consisting of instructions, coding terms and definitions. If you are a manufacturer, you subsequently must update each Baseline Report annually. If you are a user facility, you are required to submit a semiannual summary to FDA (Jan-June, July-Dec) using Form 3419, unless no reports were submitted to FDA or the manufacturer during the 6-month period in question.

In essence, the entire process is similar to the customary IRS April 15 submission (i.e., complete this section, look up this code, enter the code number in this box, etc.). The basis for the MDR program can be described as a system of "checks and balances." If the user or distributor finds a reportable event, they report to the FDA. If the manufacturer is aware of a reportable event, they report to the FDA. Subsequently, the number of reports obtained from all sources will be tallied and cross-referenced, and reports that do not "equal" for a particular device will flag the unfortunate party who, for whatever reason, failed to report. As such, the burden to comply with the new reporting requirements is placed on all three types of reporting parties. Regulatory action for noncompliance could result in civil penalties or imprisonment.

The original medical device reporting guidelines were written in the Federal Food, Drug, and Cosmetic Act, Section 519. Article 4 of that Section states that regulations "shall not impose requirements unduly burdensome to a device manufacturer, importer, or distributor taking into account his cost of complying with such requirements and the need for the protection of the public health and the implementation of this Act." Depending on the size of your company, you might need to expand your regulatory department to compensate for the increased workload necessary to comply with the requirements. For a medium-sized company, a recent editorial in a medical device industry magazine described a typical increase from one regulatory associate (in 1975) to a full department today.

This article is intended to provide you with a general outline of the diligence required to comply with the program. If you have not been to a recent seminar devoted to the MDR process, attend one soon, then fine-tune your existing complaint process to prepare for the new requirements. Re-training of all personnel is essential, as their ability to recognize a reportable event is key to your compliance. Give your company sufficient lead-time to plan for an effective reporting system, to address and document the new procedures, and to educate your staff.

To obtain more information regarding the requirements, contact DSMA (1-800-638-2041) and ask for the MDR forms, or connect to the FDA's World Wide Web site (http://www.fda.gov/) and download the MDR related documents.

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