MRx MEDICAL REPORTS EXCHANGE

SPECIAL DATA ANALYSIS 0601

Final MDR Certification Requirements

The following analysis examines requirements concerning the certification of MDR's which was suspended last July 31st by the FDA. The FDA has APPROVED a revised final rule concerning MDR Certification (21CFR805.57). The new rule implements the original rule with minor changes. ALL MANUFACTURERS AND DISTRIBUTORS MUST NOW CERTIFY ANNUALLY AS DESCRIBED BELOW.

In May of 1997 the FDA published guidance (21 CFR 806) on the subject of reporting removals or corrections of devices due to risk to health, or to remedy a violation of the U.S. Food, Drug &Cosmetics Act (FD&C). The final rule requires device manufacturers, importers, and distributors to report promptly to FDA any correction or removal of a device.

Effective Date: The effective date of the certification guidance was 19 May 1997. The rule requires annual certification. The rule on reports and corrections is effective 17 Nov. 1997. .

Medical Devices; Medical Device Reporting; Annual Certification

I. The elements of the final rule are described below. A complete text of the new regulation provisions is attached.

SUMMARY: The certification requirements allow manufacturers and distributors to designate more than one certifying official, who would each sign a certification statement for his or her identified organizational component or site; amend the certification statement to minimize concerns relating to liability from unintentional reporting errors; and indicate that the certifying official is making the certification statements, to the best of his/her knowledge and belief. The wording implies that any individual so designated bears personal as well as organizational responsibility for the truth and accuracy of certification.

BACKGROUND: The F D & C Act (the act) (21 U.S.C. 360i(d)) provides that each manufacturer, importer, and distributor shall certify that they did file a certain number of medical device reports (MDR's) in the previous 12 months or they did not file any MDR's. Distributors and manufacturers were required to certify that they filed reports for all reportable events required under the rule for the previous 12 months or to certify that they did not receive any reportable events during the reporting period (Sec. 803.57 and 804.30 (21 CFR 804.30). The December 1995 final rule required certification to be made by the company's president, chief executive officer (C.E.O.), the U.S. designated agent, or other official most directly responsible for the firm's operations. The agency reviewed its position in light of the statutory language and legislative history. In the Federal Register of July 23, 1996, the agency stayed the effective date of the certification requirement of the December 1995 final rule. In that same issue of the Federal Register the agency re-proposed a new certification requirement that the certifying official will state:

(1) He/she has read the requirements of the MDR regulation;

(2) the firm has established a system to implement MDR reporting; and

(3) following the procedures of its MDR reporting system, the firm submitted a specified number of reports, or no reports, during the certification period.

FDA is now issuing a final rule amended only by the additional statement that the certifying official is making the certification statements ``to the best of [his/her] knowledge and belief.'' The agency is taking this opportunity to stress the importance of certification by all firms covered under this rule, and by all sites or organizational components of such firms, if more than one certifying official is designated. If the firm designates more than one certifying official, all organizational components or sites must be assigned to an appropriate certifying official, so that all sites and components of a firm are covered under a certification statement.

IMPLEMENTATION: The schedule for submitting annual certifications shall correspond with the schedule provided in Sec. 807.21 (21 CFR 807.21(a)) for firm registrations, and must be followed by all firms required to certify regardless of whether the firm is required to register. Under this schedule, annual certifications will be due in either April, July, September, or December, depending on the first letter of the name of the owner or operator of the reporting firm. According to this schedule, the first group of annual certifications will be due in April 1998, for firms whose owner or operator name begins with the letters A-E. This first group of certifications will certify to MDR's submitted between the effective date of this rule and March 1998. The second group of annual certifications will be due in July 1998, for firms whose owner or operator name begins with the letters F-M. The third group of annual certifications will be due in September 1998, for firms whose owner or operator name begins with the letters N-R. The final group in this series of annual certifications will be due in December 1998, for firms whose owner or operator name begins with the letters S-Z. After initial certifications, firms shall certify annually to the MDR's submitted in the previous 12-month period ending 1 month prior to the month the certification is due, consistent with the schedule provided in Sec. 807.21(a).

Medical Device Report Annual Certification

Under the Federal Food, Drug, and Cosmetic Act, and under authority delegated to the Commissioner of Food and Drugs, 21 CFR parts 803 and 804 are amended as follows:

PART 803--MEDICAL DEVICE REPORTING

1. The authority citation for part 803 continues to read as follows: Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371, 374).

2. Section 803.1 is amended by revising paragraph (a) to read as follows:

Sec. 803.1 Scope.(a) This part establishes requirements for medical device reporting. Under this part, medical device user facilities and manufacturers must report deaths and serious injuries to which a device has or may have caused or contributed, and manufacturers must also report certain device malfunctions. Additionally, user facilities and manufacturers must establish and maintain adverse event files, and must submit to FDA specified followup and summary reports. These reports will assist FDA in protecting the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use.

3. Section 803.57 is revised to read as follows:

Sec. 803.57 Annual certification.

(a) All manufacturers required to report under this section shall submit an annual certification report to FDA, on FDA Form 3381, or electronic equivalent as approved under Sec. 803.14. The date for submission of certification coincides with the date for the firm's annual registration, as designated in Sec. 807.21 of this chapter. Foreign manufacturers shall submit their certification by the date on which they would be required to register under Sec. 807.21 of this chapter if they were domestic manufacturers. The certification period will be the 12-month period ending 1 month before the certification date, except that the first certification period shall cover at least a 6-month period from the effective date of this section, ending 1 month before the certification date.

(b) The manufacturer shall designate, as the certifying official, an individual with oversight responsibilities for, and knowledge of, the firm's MDR reporting system. A manufacturer may determine, based upon its organizational structure, that one individual cannot oversee or have complete knowledge of the operation of the reporting system at all organizational components or manufacturing sites owned by the firm. In this circumstance, the firm may designate more than one certifying official, each of whom will sign a certification statement pertaining to his/her respective identified organizational component(s) or site(s), provided that all organizational components and sites are covered under a certification statement.

(1) Name, address, and FDA registration number or FDA assigned identification number of the reporting site and whether the firm is a manufacturer;

(2) Name, title, address, telephone number, signature, and date of signature of the person making the certification;

(3) Name, address, and FDA registration number or FDA assigned identification number for each manufacturing site covered by the certification and the number of reports submitted for devices manufactured at each site;

(4) A statement certifying that:

(i) The individual certifying for the firm has read the MDR requirements under this part;

(ii) The firm has established a system to implement MDR reporting;

(iii) Following the procedures of its MDR reporting system, the reporting site submitted the specified number of reports, or no reports, during the certification period; and

(iv) The certification is made to the best of the certifying official's knowledge and belief.

(d) The name of the manufacturer and the registration number submitted under paragraph (c)(1) of this section shall be the same as the reporting site that submitted the reports required by Secs. 803.52, 803.53, and 803.55. Multi-reporting site manufacturers who choose to certify centrally must identify the reporting sites, by registration number and name covered by the certification, and provide the information required by paragraphs (c)(2) and (c)(3) of this section for each reporting site.

PART 804--MEDICAL DEVICE DISTRIBUTOR REPORTING

4. The authority citation for part 804 continues to read as follows: Authority: Secs. 502, 510, 519, 520, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 360i, 360j, 371, 374).

5. New Sec. 804.30 is added to read as follows:

Sec. 804.30 Annual certification.

(a) All distributors required to report under this section shall submit an annual certification report to FDA, on FDA Form 3381, or electronic equivalent as approved under Sec. 803.14 of this chapter. The date for submission of certification coincides with the date for the firm's annual registration, as designated in Sec. 807.21 of this chapter. The certification period will be the 12-month period ending 1 month before the certification date, except that the first certification period shall cover at least a 6-month period from the effective date of this section, ending 1 month before the certification date.

(b) The distributor shall designate, as the certifying official, an individual with oversight responsibilities for, and knowledge of, the firm's MDR reporting system. A distributor may determine, based upon its organizational structure, that one individual cannot oversee or have complete knowledge of the operation of the reporting system at all organizational components or distribution sites owned by the firm. In this circumstance, the firm may designate more than one certifying official (one for each component or site), each of whom will sign a certification statement pertaining to their respective identified organizational component(s) or site(s), provided that all organizational components and sites are covered under a certification statement.

(1) Name, address, and FDA registration number or FDA assigned identification number of the firm;

(2) Name, title, address, telephone number, signature, and date of signature of the person making the certification;

(3) Name, address, and FDA registration number or FDA assigned identification number for the distributor covered by the certification, and the number of reports submitted for devices distributed by the distributor;

(4) A statement certifying that:

(i) The individual certifying for the firm has read the MDR requirements under part 804;

(ii) The firm has established a system to implement MDR reporting;

(iii) Following the procedures of its MDR reporting system, the firm submitted the specified number of reports, or no reports, during the certification period; and

(iv) The certification is made to the best of the certifying official's knowledge and belief.

Return to Analysis Home Page