[Federal Register: January 26, 2000 (Volume 65, Number 17)]
[Notices]
[Page 4229-4230]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr26ja00-44]
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DEPARTMENT OF COMMERCE
National Institute of Standards and Technology
[Docket No. 000106008-0008-01]
RIN: 0693-XX49
National Voluntary Conformity Assessment System Evaluation
(NVCASE) Program
AGENCY: National Institute of Standards and Technology, Commerce.
ACTION: Notice.
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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
[[Page 4230]]
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 (301)
975-5414, or E-mail at robert. gladhill@nist.gov.
FOR FURTHER INFORMATION CONTACT: Robert L. Gladhill, NVCASE Program
Manager, at NIST, 100 Bureau Drive, Mail stop 2100, Gaithersburg, MD
20899-2100, telefax: (301) 975-5414, or E-mail:
robert.gladhill@nist.gov.
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.
[FR Doc. 00-1744 Filed 1-25-00; 8:45 am]
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