[Federal Register Volume 63, Number 127 (Thursday, July 2, 1998)]
[Pages 36247-36248]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 98-17597]



Food and Drug Administration
[Docket No. 95N-0195]

Agreement on Mutual Recognition Between the United States of 
America and the European Community; Third Party Review Program Under 
the Sectoral Annex on Medical Devices; Conformity Assessment Bodies

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.


SUMMARY: The Food and Drug Administration (FDA) is identifying the 
process for designating Conformity Assessment Bodies (CAB's) under the 
Sectoral Annex on Medical Devices to the Agreement on Mutual 
Recognition Between the United States of America and the European 
Community (MRA). The MRA was signed in London on May 18, 1998, but it 
has not entered into force. FDA has published a proposed rule on the 
parts of the MRA affecting FDA-regulated products. This notice 
announces the process for CAB's to become eligible for designation 
under the Sectoral Annex on Medical Devices (Medical Devices Annex). 
The availability of the draft guidance detailing the requirements for 
performing evaluations, training for CAB's, and content of evaluation 
reports by FDA is announced elsewhere in this issue of the Federal 
Register. Also announced elsewhere in this issue of the Federal 
Register is an emergency processing request for Office of Management 
and Budget review of the information collection provisions of this 
    Regarding the U.S./European Community MRA: John F. Stigi, Director, 
Division of Small Manufacturers Assistance (HFZ-220), Center for 
Devices and Radiological Health, Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-443-6597, or FAX: 301-443-8818.
    Regarding the process for being recognized to assess U.S. CAB's or 
for naming a recognized accreditor: Robert L. Gladhill, Conformity 
Assessment Systems Evaluation, National Institute of Standards and 
Technology, NN, 282 Gaithersburg, MD 20899, 301-975-4273, or FAX: 301-


I. Background

    On June 20, 1997, the United States and the European Community (EC) 
completed negotiation of the MRA that covered a variety of product 
sectors, including telecommunication equipment, recreational craft, 
pharmaceuticals, and medical devices. The Medical Devices Annex applies 
only to medical devices manufactured for export to the United States or 
EC. The EC consists of the following member States: Austria, Belgium, 
Denmark, Finland, France, Germany, Greece, Ireland, Italy, Luxembourg, 
The Netherlands, Portugal, Spain, Sweden, and the United Kingdom. FDA 
issued a proposed rule on April 10, 1998 (63 FR 17744), to add a new 
section to its regulations setting out requirements through which FDA 
may normally endorse certain reports of conformity assessments. The 
Medical Device Annex applies to reports of quality system evaluations 
of all medical devices and premarket evaluations of selected medical 
devices provided by designated conformity assessment bodies.
    Assuming the MRA enters into force and a final rule becomes 
effective, a 3-year transition period will start during which time both 
sides will engage in confidence building activities. After the 3-year 
transition period and the confidence building activities are 
successfully completed, the operational period will begin.
    The MRA consists of a framework agreement and individual sectoral 
annexes (i.e., those product sectors covered by the MRA). The framework 
agreement covers the general aspects of the implementation of the 
agreement as well as the requirements governing the CAB's, such as 
designation, listing, suspension, and withdrawal.
    Within the framework agreement there is a provision that FDA and EC 
Designating Authorities review the Medical Devices Annex. It is 
anticipated that aspects of the Medical Devices Annex will be modified 
by agreement of FDA and EC Designating Authority as laws and policies 
change. This provision was included because of FDA's concern during the 
negotiations that there could be a change in the status of the FDA 
Third Party Review Pilot Program for medical devices that would change 
the nature of the agreement.
    Under the MRA, an EC CAB could conduct quality system evaluations 
for all classes of devices and premarket 510(k) evaluations for 
selected devices based on FDA requirements. Similarly, a U.S. CAB could 
conduct quality system evaluations for all classes of devices and 
product type examinations and verifications for selected devices based 
on EC requirements. In addition, an alert system would be set up during 
the transition period and maintained thereafter by which FDA and 
regulatory authorities will notify each other when there is an 
immediate danger to public health. As part of that system, FDA and EC 
will notify each other of any confirmed problem reports, corrective 
actions, or recalls.
    The MRA may: (1) Be an important means of facilitating movement of 
medical devices important to human health between the United States and 
EC, (2) enhance public health by allowing better use of scarce FDA 
resources, (3) enhance harmonization of U.S. and EC regulatory systems, 
and (4) permit FDA to better utilize its regulatory resources to focus 
on manufacturers located in other countries.
    Under the MRA, both the United States and the EC may eventually be 
able to save resources by utilizing evaluations of manufacturers 
conducted by the other party, thereby saving overseas travel time and 
expense. However, CAB's will be required to participate in rigorous 
joint activities in order to demonstrate proficiency in conducting FDA 
and EC evaluations. Based on demonstrated proficiency during a 3-year 
transition period, both FDA and EC are expected to ``normally endorse'' 
evaluations conducted by the other party's CAB's, while reserving the 
final decision making to themselves and reserving the right to conduct 
their own evaluations should significant deficiencies be found in any 

II. Third Party Review Program

    The Medical Devices Annex identifies legislation, regulations, and 
related procedures under which: (1) Products are regulated as medical 
devices by each party (i.e., FDA and the EC); (2) CAB's are designated 
and confirmed; and (3) evaluation reports are prepared. Assuming the 
MRA enters into force and a final rule becomes effective, FDA will be 
the Designating Authority for U.S. CAB's and the EC Regulatory 
Authorities will be the Designating Authority for EC CAB's. FDA intends 
to use the National Voluntary Conformity Assessment System Evaluation

[[Page 36248]]

(NVCASE) administered by the National Institute of Standards and 
Technology (NIST) of the U.S. Department of Commerce to recognize one 
or more accreditation bodies that, in turn, will assess potential U.S. 
CAB's seeking to be designated under the MRA to assess medical devices 
produced for the EC market. FDA will consider the recommendations made 
by the recognized accreditation bodies from June 1, 1998, until October 
1, 1998, review the list of recommended CAB's, and then designate U.S. 
CAB's that meet criteria for technical competence set forth in the 
Medical Devices Annex, assuming the MRA enters into force and a final 
rule on the MRA becomes effective. FDA intends to conduct training for 
EC CAB's from October 14 to 23, 1998.
    Assessment of prospective U.S. CAB's for purposes of conducting 
quality system evaluations and product type-examination and 
verifications will be conducted under the NVCASE program under the 
procedures set forth in 15 CFR part 286. Prospective U.S. CAB's and 
accreditation bodies should contact NIST for additional information. 
Applications for designation should include sufficient information to 
address the qualifications for CAB's set forth in Article 1, Paragraph 
1 of the Medical Devices Annex of the MRA. At a minimum, qualified U.S. 
CAB's should have knowledge of:
    (1) Council Directive 90/385/EEC of June 20, 1990, on active 
implantable medical devices OJ No. L 189, 20.7.1990 (p. 17). Conformity 
assessment procedures: Annex 2 (with the exception of section 4), Annex 
4, and Annex 5.
    (2) Council Directive 93/42/EEC of June 14, 1993, on medical 
devices OJ No. L 169, 12.7.1993 (p. 1). Conformity assessment 
procedures: Annex 2 (with the exception of section 4), Annex 3, Annex 
4, Annex 5, and Annex 6.
    Assuming the MRA enters into force and a final rule becomes 
effective, designation of EC CAB's for the purpose of conducting 
quality system evaluations and premarket 510(k) evaluations will be 
conducted in accord with the Medical Devices Annex. At a minimum, 
qualified EC CAB's should have knowledge of:
    (1) The Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321 et 
    (2) The Public Health Service Act (42 U.S.C. 201 et seq.),
    (3) Regulations of the United States Food and Drug Administration 
(21 CFR parts 800 to 1299); and
    (4) The Federal Register document on the pilot program for third-
party review of selected premarket notifications for medical devices 
that was published on April 3, 1996 (61 FR 14789 at 14796).
    Prospective EC CAB's should contact their European Regulatory 
Authority, not FDA, for further information. Following designation, the 
EC CAB's can expect to be monitored through FDA surveillance audits at 
intervals determined by the agency.

III. Environmental Impact

    The agency has determined under 21 CFR 25.34(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

IV. Analysis of Impacts

    FDA has examined the impacts of the U.S./EC MRA third party review 
program under Executive Order 12866 and the Regulatory Flexibility Act 
(Pub. L. 96-354), as amended by subtitle D of the Small Business 
Regulatory Fairness Act of 1996 (Pub. L. 104-121), and the Unfunded 
Mandates Reform Act of 1995 (Pub. L. 104-4). Executive Order 12866 
directs agencies to assess all costs and benefits of available 
regulatory alternatives and, when regulation is necessary, to select 
regulatory approaches that maximize net benefits (including potential 
economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this voluntary program is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, the program 
is not a significant regulatory action as defined by the Executive 
Order and so is not subject to review under the Executive Order.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. This regulation provides alternative review options 
for certain types of submissions. This is a voluntary program which 
imposes no additional requirements on regulated industry. Accordingly, 
the agency certifies that the program, if implemented, would not have a 
significant economic impact on small entities. Therefore, under the 
Regulatory Flexibility Act, no further analysis is required.

    Dated: June 24, 1998.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 98-17597 Filed 7-1-98; 8:45 am]