Edward M. Basile and Elizabeth A. Schmidtlein
In addition to the basic reporting requirements for manufacturers and device user facilities, the new regulations contain several administrative and procedural provisions. These are summarized in Table II.
Table II. Summary of other MDR requirements. (The requirement for designation of a U.S. agent has been stayed indefinitely.)
|Requirement||Applies to||Summary||Changes from 11/26/91 Proposal|
|Designation of U.S. agent||Foreign manufacturers.||Foreign manufacturers must designate an agent in the United States who will register and submit MDR reports, conduct or obtain information about investigations, forward reports to the manufacturer, and maintain complaint files on behalf of the manufacturer. Agent subject to same requirements as a manufacturer. (Requirement stayed).||Clearly delineated responsibilities of agent.|
|Exemptions, variances, and alternative reporting||User facilities and manufacturers.||Exemptions, variances, or alternatives to any or all of the reporting requirements may be granted upon request or at the discretion of FDA.||Added variances.|
|Files||User facilities and manufacturers.||Records of complaints and MDR reports must be kept for two years or, for manufacturers, the expected life of the device, if longer.||None.|
|Written MDR procedures.||User facilities and manufacturers.||Written procedures must be developed, maintained, and implemented for identification, evaluation, and timely submission of MDR reports, and compliance with recordkeeping requirements.||Eliminated training and education programs for user facilities and manufacturers.|
Written Procedures and Recordkeeping. The new MDR regulations require both manufacturers and user facilities to develop, maintain, and implement written procedures that set up systems (1) for the timely and effective identification, communication, and evaluation of adverse device events; (2) for a standardized review process to evaluate the reportability of an event; and (3) for the timely filing of reports with FDA.39
The regulations also specifically require written procedures for documentation and recordkeeping. These procedures must include requirements for documenting and retaining (1) any information evaluated to determine if an event is reportable, (2) all MDRs and information submitted to FDA and to manufacturers, and (3) any information evaluated for the preparation of semiannual reports or certification. In addition, the procedures must ensure access to information that facilitates timely follow-up and inspection by FDA. Obviously, all of these procedures will be reviewed as part of future FDA inspections.
Manufacturers and user facilities are also required to establish and maintain prominently identified MDR event files in written or electronic form that contain information and documentation relating to adverse events. According to FDA's draft guidance document, manufacturers' MDR event files should contain the following (or references to where such items may be located):
- A copy of the initial complaint record containing the reportable information.
- Documentation of the entity's attempts to follow up and obtain additional information about the event.
- When information cannot be obtained and submitted, an explanation of why it cannot.
- Copies of any relevant test and lab reports, service reports, and reports of investigations.
- Documentation related to the deliberations and decision-making processes used to determine the reportability of the event.
- Documentation of the final assessment of the event and any corrective action taken.
- Copies of MDR reports and other information submitted to FDA, distributors, or manufacturers.40
User facilities must maintain MDR event files for two years from the date of the event, while manufacturers are required to maintain these files for either two years from the date of the event or the expected life of the device, whichever is greater. FDA has defined expected life of a device as "the time that a device is expected to remain functional after it is placed in use." How to calculate the expected life of a device has not been defined, but presumably companies will do so based on their experience marketing the device. In FDA's guidance on manufacturer reporting, the agency stated that there are some categories of devices that will have an indefinite expected life, since their end of life cannot be estimated. Manufacturers of devices with an indefinite expected life may want to request a variance from the record retention requirement to avoid having to retain report files for these devices indefinitely.
Requests for Additional Information. Under the new regulations, FDA may request additional or clarifying information if it determines that such information is necessary to protect public health.41 The request must clearly relate to a reported event, state the reason or purpose for which the information is being requested, and include the date by which the information is to be submitted.
HIMA criticized this requirement as being vague, lacking adequate guidance about the conditions under which additional information might be required, and providing no assurance that entities will be provided sufficient time to comply. HIMA suggested that, at a minimum, the regulation should be amended to make clear that the agency will allow a company a reasonable amount of time to comply with the request and that the company will not be considered to be in violation of the regulations if it is unable to obtain the requested information after making a reasonable attempt to do so. These suggestions, however, were rejected.
Public Availability of Reports. Mandatory reports submitted to FDA and records of telephone reports are subject to public disclosure via Freedom of Information (FOI) requests. Before releasing the reports, however, the agency is required to delete certain information, including confidential commercial or financial information, personal or medical information (including serial numbers of implanted devices) that might constitute an invasion of privacy, and names or other identifying information of third parties that voluntarily submit an adverse event report. Under certain conditions, the new regulations also prohibit FDA from disclosing the identity of a device user facility that has filed an MDR report.42
Computerized Forms and Electronic Reporting. FDA is encouraging companies to computerize the forms required for MDR reporting, but firms cannot make major changes to the appearance and format of the forms and must receive written approval from FDA prior to using them. According to FDA's guidance document on manufacturer reporting, the Center for Devices and Radiological Health is also encouraging companies to submit MDR reports electronically, subject to prior written consent, and is now developing an Electronic Data Interchange protocol to facilitate such reporting. Electronic reports include disks, magnetic tape, and computer-to-computer transmissions.
Enforcement. Noncompliance with the MDR regulations is prohibited under the FD&C Act and may result in a variety of FDA enforcement actions ranging from warning letters to injunction proceedings, civil penalties, and criminal penalties.
Effect on Product Liability. For user facilities, 21 USC 360i(b)(3) states that no report by device user facilities, their employees or individuals officially affiliated with them, or physicians "shall be admissible into evidence or otherwise used in civil action involving private parties unless the facility making the report . . . had knowledge of the falsity of the information contained in the report." There is no such statutory protection for manufacturers or distributors. However, the MedWatch form contains a general disclaimer statement, and the regulations permit a reporting entity to submit its own disclaimer denying that the report or information constitutes any type of admission that the device or reporting entity or the entity's employees caused or contributed to the event reported.
As a practical matter, manufacturers should be aware that violations of the FD&C Act can have significant product liability implications. When a manufacturer violates the statute or implementing regulation, a court can find without any more evidence that the manufacturer was negligent in the context of a product liability case.43 Indeed, a failure to file a required MDR report may have product liability implications even though FDA does not take regulatory action.44
The new MDR regulations contain several substantial new requirements for medical device manufacturers that will clearly add considerably to every manufacturer's costs of complying with MDR reporting. The new MDR regulations require manufacturers to provide FDA with a greater quantity of information, and the required information is of considerably greater specificity. There is likely to be substantially more paperwork and additional work in investigating and analyzing whether particular events are reportable.
The benefits to be derived from providing all this information to FDA are dubious at best. When Congress enacted SMDA, it felt that additional postmarket surveillance of products was necessary to balance what the 1990 Congress perceived as SMDA's relaxed premarket review requirements. In fact, premarket review under SMDA has become more rigorous and thus the need for additional postmarket surveillance is questionable. After some experience with the new MDR regulations, it would be prudent for Congress to revisit the MDR requirements to see whether the public health has really benefited. If evidence of public health benefits is lacking, the regulations should then be scaled back substantially.
In the meantime, however, manufacturers will have to cope with a cadre of increasingly complex regulatory requirements that, like all of FDA's regulations, are likely to be strictly enforced. Indeed, manufacturers should expect to find MDR event files and MDR procedures at the top of FDA investigators' lists of documents to review during routine inspections in the months to come.
1. Federal Register, 60 FR:63578 (Final Rule, Medical Device User Facility and Manufacturer Reporting).
2. However, in a separate rule published in the Federal Register last July, FDA revoked the distributor reporting certification requirement that went into effect on May 28, 1992. See 61 FR:38346 (Final Rule, Medical Device Distributor and Manufacturer Reporting, Stay of Effective Date and Revocation of Final Rule on Ceritification).
3. 49 FR: 36326 (Final Rule, Medical Device Reporting).
4. Federal Food, Drug, and Cosmetic Act (FD&C Act), sect. 519, 21 USC 360i, as amended by the Medical Device Amendments of 1976, Pub. L. 94-295, 90 Stat. 539, 1976.
5. FD&C Act, sect. 519, as amended by the Safe Medical Devices Act of 1990 (SMDA), Pub. L. 101-629, 104 Stat. 4511, 1990.
6. FD&C Act, sect. 519(a)(1) and (2), as amended by the Medical Device Amendments of 1992 (MDA of 1992), Pub. L. 102-300, 106 Stat. 238, 1992.
7. FD&C Act., sect. 519(a)(3), as amended by MDA of 1992.
8. 56 FR: 60024 (Tentative Final Rule, Medical Device User Facility, Distributor, and Manufacturer Reporting).
9. 21 CFR 807.20.
10. See 61 FR: 3834838349 (Proposed Rule, Medical Device Reporting, U.S. Designated Agents).
11. 21 CFR 803.50.
12. 21 CFR 803.3(c).
13. 60 FR: 63583.
14. Medical Device Reporting for Manufacturers (draft guidance document), Rockville, MD, FDA, Center for Devices and Radiological Health, May 1996, at 1920 [Hereinafter Medical Device Reporting for Manufacturers.
15. 21 CFR 803.20(c).
16. See 21 CFR 820.162 and 820.198.
17. See 21 CFR 803.22.
18. 60 FR: 63583.
19. Medical Device Reporting for Manufacturers at 51.
20. Medical Device Reporting for Manufacturers at 11.
21. 21 CFR 803.3(d).
22. See 60 FR:63582.
23. 21 CFR 803.3(aa).
24. 21 CFR 803.3(m).
25. 21 CFR 803.50(a)(2).
26. See Medical Device Reporting for Manufacturers at 13.
27. 21 CFR 803.3(c) and 803.53(a).
28. 21 CFR 803.3(y).
29. See Medical Device Reporting for Manufacturers at 20.
30. 21 CFR 803.53.
31. 21 CFR 803.50(b).
32. 21 CFR 803.56.
33. 60 FR: 63591.
34. 61 FR: 38346.
35. 61 FR: 38348.
36. 61 FR: 39868.
37. 21 CFR 803.3(e).
38. 21 CFR 803.58.
39. 21 CFR 803.17.
40. See Medical Device Reporting for Manufacturers at 3839.
41. 21 CFR 803.15.
42. 21 CFR 803.9(c); see also FD&C Act, sect. 519(b)(2).
43. See Tool v. Richardson-Merrill, 60 Cal. Rptr. 398, 1987.
44. See Stanton v. Astra Pharmaceutical Products, 718 F.2d 553, 3d Cir. 1983.