FDA's New MDR Regulations:What Manufacturers Need to Know 2489

Edward M. Basile and Elizabeth A. Schmidtlein CONTINUED

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Reporting Time Frames. Under the new regulations, a reportable adverse event must be submitted as either a 5-day or 30-day report. A 5-day report is required only in two situations. First, a report is required within five work days when an employee with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or with duties relating to the collection and reporting of adverse events, becomes aware from any information—including trend analysis—that a reportable MDR event or events necessitates remedial action to prevent an unreasonable risk of substantial harm to the public health.²⁷ The term remedial action is broadly defined as "any action other than routine maintenance or servicing of a device where such action is necessary to prevent recurrence of a reportable event."²⁸ However, FDA has clarified in its guidance document that actions taken to fix a single device involved in a reportable event are not remedial actions, and that a 5-day report is not required every time remedial action is taken but only when it is taken to prevent an unreasonable risk of substantial harm to public health.²⁹ Thus, the question that remains open to interpretation and potential disagreement is what constitutes an "unreasonable risk of substantial harm to the public health."

A report is also required within five work days when any employee of a manufacturer becomes aware of a reportable event for which it has received a written request from FDA.³⁰ When such a request is made by FDA, the manufacturer is required to submit 5-day reports for all subsequent adverse events of substantially the same nature for the time period specified in the request. FDA's decision to require 5-day reports for particular events may be based on its review of 30-day reports, inspection reports, user reports, or any other source of information.

All other reportable events qualify for a 30-day report, which must be filed within 30 days—calendar days, not work days—of any employee (not just persons with certain management or MDR reporting responsibilities) receiving or otherwise becoming aware that a reportable event may have occurred.

Mechanics of Reporting. FDA has adopted the use of a single reporting form, MedWatch Form 3500A, for manufacturers, user facilities, and distributors. Voluntary reports by patients or health-care professionals may still be submitted using MedWatch Form 3500. The agency has also developed a MedWatch Mandatory Reporting Form Coding Manual that contains codes for hundreds of reportable adverse events.

The regulations require manufacturers to provide on the MedWatch reporting forms all required information that is "reasonably known to them," which by definition includes any information that can be obtained by contacting a user facility, distributor, and/or other initial reporter; any information in the manufacturer's possession; or any information that can be obtained by analysis, testing, or other evaluation of the device.³¹

The required form compels manufacturers to report data on reportable events with much greater specificity than was required under the old MDR regulations. New and potentially burdensome required data elements include: (1) patient identifier, age or date of birth, gender, weight; (2) identification of outcomes attributed to the adverse event and/or product problem; (3) description of the event or problem, including how the device was involved, patient follow-up or required treatment, and any environmental considerations that may have influenced the event; (4) description of relevant tests, including dates and lab data; (5) description of relevant history, including pre-existing medical conditions; (6) concomitant medical products and therapy dates; (7) summary of evaluation of returned devices; (8) device manufacture date; (9) evaluation codes; and (10) remedial action taken and whether it was reported as a removal or correction.

After filing a report, if a manufacturer obtains information that was unknown or unavailable when the initial report was filed, it must submit a supplemental report containing the new information.³² The new information must be submitted within one month of its receipt.

Annual Certifications. Under section 519(d) of the FD&C Act, manufacturers are required to submit annual statements certifying that a certain number of reports were filed, or that no reports were filed, during the previous 12-month period. This requirement was added by SMDA. FDA, however, decided to broaden the certification statement in the new regulations and require manufacturers to certify that all reportable events were submitted, as well as the number of reports submitted. As discussed below, FDA has stayed the new regulations implementing the certification requirement.

Section 519(d) of the FD&C Act expressly authorizes FDA to require manufacturers to certify to the number of MDR reports submitted, and no more. In mandating that manufacturers certify that all reportable events were submitted, FDA exceeded the scope of its statutory authority. HIMA made this argument in its comments and requested that FDA modify the certification language in the regulation to reflect the statutory language.

In the preamble to the final rule, FDA maintained that the purpose of such certification is "to ensure reporter compliance with MDR requirements by certifying that all reportable events have been submitted" and that this purpose "would be thwarted and the certification requirement rendered meaningless if it were limited to simply certifying the number of reports submitted."³³ FDA stated that this requirement was consistent with congressional intent because a General Accounting Office (GAO) report recommending that the certification state not only the number of reports filed, but also that the firm received or became aware of information concerning only these events, was referenced in the legislative history of SMDA.

While the legislative history of SMDA makes clear that early in the legislative process congressional committees considered requiring device manufacturers, importers, and distributors to certify that reports were submitted for all reportable events, it is also clear that Congress ultimately rejected this language in favor of the simpler requirement of certifying the number of reports filed or that no reports were filed. The GAO report language may be referenced in initial versions of both the House and Senate bills, H.R. 3095 and S. 3006. However, the GAO language was not retained when these bills were reported at the subcommittee, full committee, or conference committee levels.

In its comments, HIMA stated that the broader certification was not adopted by Congress "because of objections that such certification would impose new potential liability on the certifying party in the event the certification was found to be incorrect." The association explained that Congress opted to drop the broader certification rather than attempt to define the circumstances under which such additional liability would be appropriate. HIMA further stated that the requirement is unacceptable because it subjects the reporting entity to an unreasonable risk of legal action due to the "vague, highly subjective, and constantly changing FDA interpretations of the MDR rules."

In response to comments objecting to and requesting reconsideration of the final regulations on certification, FDA published a notice in July postponing the effective date of the certification requirements for manufacturers and also revoking the certification requirement for distributors under 21 CFR 804.30, for purposes of consistency.³⁴

At the same time, FDA published a proposed rule to amend the certification requirement.³⁵ The agency is now proposing that manufacturers submit a statement certifying that: (1) the individual certifying for the firm has read the MDR requirements under part 803; (2) the firm has established a system to implement the MDR requirements; and (3) following the procedures in its reporting system, the reporting site has submitted a specified number of reports, or no reports, during the 12-month certification period.

This proposal may still be objectionable, depending on what it means to certify that a certain number of reports have been submitted following procedures of the company's medical device reporting system. If it means that a firm has followed procedures ensuring that all reportable adverse events are reported, then the net effect of the revised language proposed by FDA is basically unchanged.

The proposed rule would also allow manufacturers to designate an individual with oversight responsibilities for and knowledge of the firm's medical device reporting system as the certifying official, rather than requiring the firm's president or CEO to execute the certification. Additionally, FDA would allow a firm to have more than one certifying official, each with responsibility over an identified organizational component or site.

Baseline Reports. As initially published, the final regulations require device manufacturers to submit a baseline report using FDA form 3417 the first time an MDR report is submitted for a device model, and to update the information contained in each baseline report each year during the anniversary month in which the original MDR and baseline report were submitted.

FDA initially requested that manufacturers disclose the following categories of information in baseline reports: (1) manufacturer identification information; (2) product identification information, including device family, brand name, generic name, model number, catalog number, product code, and any other product identification number or designation; (3) information to identify any device previously named in a baseline report that is substantially similar; (4) product marketing information (e.g., 510(k) or PMA number), and whether the device is currently the subject of an approved postmarket study; (5) the date the device was initially marketed and, if applicable, the date marketing of the device ceased; (6) the device shelf life and either the expected life of the device or a statement that its expected life is not established or is indefinite; (7) denominator data, including the number of devices manufactured and distributed in the last 12 months, an estimate of the number of devices in current use, and a brief description of methods used to estimate the number of devices distributed and in current use. However, as discussed below, FDA has stayed the requirement that manufacturers submit denominator data in baseline reports.

In comments on FDA's final rule, HIMA argued that the baseline reporting requirement should be deleted because section 519(a)(4) of the FD&C Act prohibits promulgation of reporting regulations that are unduly burdensome to a manufacturer, taking into account the cost to the manufacturer of complying and the need to protect the public health and implement the statute. If FDA decides to retain a baseline reporting requirement, HIMA has recommended that it be initiated as a pilot program for a limited number of devices to allow the agency and industry to weigh the value of the information gained against the burden to industry of providing it. HIMA further recommended that FDA define the term device model using the same definition provided for device family in the final rule to prevent the possible interpretation that device model means catalog number.

The most controversial part of the baseline reporting requirement is the submission of sales and marketing information, which has been dubbed "denominator data" because FDA intends to use this information as the denominator to which the number of reports for a particular device model is compared, thereby allowing the agency to calculate rates of reported events for a particular device and assess the significance of device failures.

HIMA expressed concern about the requirement that manufacturers submit proprietary financial data as well as sales, pricing, and research data in baseline reports, noting that these data are not even available for inspection under section 704(a)(1) of the FD&C Act. HIMA stated that manufacturers' internal trend analyses—which are available for inspection during periodic device establishment inspections—would provide FDA with any additional information needed for further assessment of medical device reports.

FDA has presumed the authority to require general baseline data from its interpretation of congressional intent. There is, however, no express support for this requirement in the statute, and the courts do not look favorably on agency attempts to infer legal authority where no express authority exists in the statute. This is particularly true where Congress's delegation of authority is narrow and specific and leaves the agency little discretion.

Congressman Fred Upton (R–MI) recommended in a June 28, 1996, letter to FDA that an 18-month pilot program be set up for the baseline reporting requirement. He recommended that the study results first be evaluated by the GAO. Then, a working group composed of officials from FDA, the Office of Management and Budget (OMB), the Department of Health and Human Services (HHS), and Vice President Gore's National Performance Review Board officials would study GAO's findings and make suggestions to Congress regarding how to implement the baseline reporting requirements. Upton also stated that FDA had exceeded its statutory authority under SMDA in promulgating the baseline reporting requirements and had violated the spirit of the Paperwork Reduction Act and Vice President Gore's initiative to create government agencies that work more efficiently at less cost.

In response to comments expressing concern about the requirement that manufacturers submit denominator data in baseline reports, FDA has stayed this requirement and opted to conduct a pilot program to "analyze how certain variables affect the denominator data and how that data is used."³⁶ FDA estimates that completion of the program will take 12 to 18 months. Thereafter, the agency will lift the stay, retain it, or amend the baseline reporting regulations.

Another aspect of the baseline reporting that presents difficulties is the concept of grouping devices together into "device families." FDA has defined device family as a "group of one or more devices manufactured by or for the same manufacturer and having the same (i) basic design and performance characteristics related to device safety and effectiveness; (ii) intended use and functions; and (iii) device classification and product code."³⁷ The regulations further provide that devices with minor differences unrelated to safety or effectiveness can be grouped in the same device family, and that manufacturers may consider brand name, common name, and whether devices were introduced under the same 510(k) or PMA in grouping devices into families.

Given that considerable discretion appears to have been afforded manufacturers in deciding which devices may be grouped together, manufacturers will need to consider the pros and cons of narrow versus broad device families in deciding what approach works best for their specific product or product lines. For example, broadly defined device families will result in a larger total number of devices marketed into which to divide the number of MDRs. In addition, the more devices that are grouped into a single family, the fewer the baseline reports that need to be submitted. On the other hand, a narrow definition of device families may narrow the scope of future inquiries resulting from the agency's analysis of MDR reports for a particular family.

Foreign Manufacturers. The final regulations require, for the first time, that MDR reports be filed for all foreign manufacturers whose devices are distributed in the United States. Rather than requiring foreign manufacturers to submit MDR reports directly to FDA, however, the final regulations require foreign manufacturers to designate a U.S. agent to be responsible for fulfilling the MDR requirements on behalf of the foreign manufacturer, as well as to maintain complaint files, register, list, and submit premarket notifications for the foreign manufacturer.³⁸

A week before the new regulations were scheduled to go into effect, FDA decided to stay the effective date of the U.S. agent requirement and announced its intent to reconsider it.^{34, 35} The agency stated that it had received comments expressing concern about this requirement following publication of the final regulations, particularly concerns regarding the difficulty in finding individuals willing to assume the responsibilities of becoming a designated agent and the high cost of compensating such individuals.

HIMA had requested that FDA begin notice-and-comment rule making on this issue because the U.S.-designated-agent regulations would impose substantial new requirements that, as far as HIMA was aware, were never before issued in proposed form with the opportunity for interested parties to comment. HIMA further noted that, in its view, the Administrative Procedure Act requires FDA to use notice-and-comment rule making when seeking to adopt these types of new, substantive requirements.

FDA decided to proceed with notice-and-comment rule making, as requested by HIMA, and has requested comments regarding who may best perform the duties provided under the stayed regulation. FDA stated that it intends to address this issue when it proposes new regulations to revoke the existing reporting requirements for distributors and importers found in 21 CFR 804 and replace them with requirements consistent with the new manufacturer and user facility requirements. FDA also stated that it has already tentatively concluded that it should propose to delete two aspects of the U.S.- designated-agent regulations: (1) the requirement for the designated agents to issue annual certification on behalf of foreign manufacturers, and (2) the requirement that foreign manufacturers submit premarket notifications through U.S. designated agents.

According to FDA, the stay does not relieve foreign manufacturers of the responsibility of complying with the MDR regulations. FDA stated in the preamble to the final rule staying the effective date of the U.S.-designated-agent requirements that, under the new regulations, foreign manufacturers are subject to the MDR regulations because they now are included in the definition of manufacturer (any person who "manufactures, prepares, propagates, compounds, assembles, or processes a device by chemical, physical, biological, or other procedure"). However, FDA further stated that during the stay, existing regulations regarding registration, listing, and premarket notification will remain in effect. Thus, for foreign manufacturers, device listing is still required and registration remains voluntary. Foreign manufacturers are also expected to continue to submit their own 510(k) applications until the stay is lifted.

NEXT: Requirements for User Facilities

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