00-1744. National Voluntary Conformity Assessment System Evaluation (NVCASE) Program

AGENCY:

National Institute of Standards and Technology, Commerce.

ACTION:

Notice.

SUMMARY:

The National Institute of Standards and Technology (NIST) hereby announces the establishment of a sub-program under the National Voluntary Conformity Assessment System Evaluation (NVCASE) program to recognize bodies that accredit quality system registrars that register organizations that produce medical devices. This sub-program is being established in accordance with NVCASE regulations in response to a request from a Federal Agency, the Food and Drug Administration (FDA). Accreditation bodies recognized by NIST may then accredit quality system registrars to register applicable organizations that demonstrate that they satisfy designated foreign or domestic mandated regulatory requirements.

The action taken under this notice addresses both generic and specific NVCASE requirements to allow NIST to support the FDA in fulfilling its obligations as designating authority under the current United States (U.S.)/European Union (EU) Mutual Recognition Agreement (MRA) medical devices sectoral annex. If additional MRAs covering medical devices are negotiated between the United States and another country or region, additional specific requirements may also be included under this NVCASE activity.

Sub-program requirements have been developed in accordance with NVCASE regulations and with public consultation. Public input was obtained at an open meeting on April 15, 1999, and from comments received through May 15, 1999.

DATES:

Applications will be received beginning February 1, 2000.

ADDRESSES:

Applications for recognition may be obtained from, and returned to, Robert L. Gladhill, NVCASE Program Manager, NIST, 100 Bureau Drive, Mail stop 2100, Gaithersburg, MD 20899-2100, by fax [phone], or E-mail at robert. [e-mail].

FOR FURTHER INFORMATION CONTACT:

Robert L. Gladhill, NVCASE Program Manager, at NIST, 100 Bureau Drive, Mail stop 2100, Gaithersburg, MD 20899-2100, telefax: [phone], or E-mail: [e-mail].

SUPPLEMENTARY INFORMATION:

This NVCASE sub-program to recognize accreditation bodies that accredit quality system registrars is being established in accordance with the NVCASE Regulations (15 CFR part 286.2(b)(3)(ii)). The generic requirements and specific criteria for this NVCASE sub-program have been established in accordance with NVCASE regulations (15 CFR Part 286.5). Public input on the establishment of both generic requirements and specific criteria for the medical devices sector was received during an open workshop held at the Department of Commerce on April 15, 1999. This workshop was announced in the Federal Register vol. 64, No. 42/Thursday, March 4, 1999. Follow-up comments were accepted from the public through May 15, 1999.

NIST will apply the generic requirements contained in the International Organization for Standardization/International Electrotechnical Commission (ISO/IEC) Guide 61—“General Requirements for Assessment and Accreditation of Certification/Registration Bodies” to all applicant accreditation bodies. Quality system registrars applying to recognized accreditors shall be assessed against the requirements of ISO/IEC Guide 62—“General Requirements for Bodies Operating Assessment and Certification/Registration of Quality Systems.” These generic requirements will be supplemented by specific sectoral criteria contained in individual supplements to the NVCASE Program Handbook, for example, European Commission document MEDDEV 2.10/2 “Designation and Monitoring of Notified Bodies within the framework of the directives on medical devices.” Such specific sectoral criteria are developed through consultation with the public and appropriate experts.

As stated in the NVCASE regulations (15 CFR Part 286.4), the NVCASE program is operated on a cost reimbursement basis. It is open for voluntary participation by any U.S. based body that conducts activities relating to conformity assessment falling within the program's scope. Pursuant to this notice, NIST will accept applications from interested accreditation bodies for recognition to accredit quality system registrars under the U.S./EU MRA medical devices sectoral annex. Prospective accreditation bodies must submit a complete application and required fees by March 15, 2000 in order to be included in the initial group to be evaluated.

The evaluation of the first group of accreditation bodies applying for NVCASE recognition will begin on or about April 3, 2000. All accreditation bodies that have submitted a complete application and required fees to NIST by March 15, 2000, will be included in this initial group. Applications received subsequently will be considered on an as-received basis for evaluation after the initial group of applicants has been considered.

NIST expects to announce recognition of qualified accreditation bodies in the initial applicant group on or about June 1, 2000. On or about the same time, NIST also expects to identify and list an initial group of qualified registrars. Each registrar listed under the provisions of the U.S./EA MRA will be designated by NIST as a conformity assessment body (CAB).

This notice contains a collection of information requirement subject to the Paperwork Reduction Act. The collection of information has been approved by OMB under the following control Number : 0693-0019.

Notwithstanding any other provision of law, no person is required to respond nor shall a person be subject to a penalty for failure to comply with a collection of information subject to the requirements of the Paperwork Reduction Act unless that collection of information displays a currently valid Office of Management and Budget Control Number.

Dated: January 18, 2000.

Karen H. Brown,

Deputy Director.