99-5385. Announcement of a Public Workshop Regarding Conformity Assessment Bodies for the Medicare Devices Annex of the US/EC Mutual Recognition Agreement

[Federal Register Volume 64, Number 42 (Thursday, March 4, 1999)]
[Notices]
[Page 10449]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-5385]


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DEPARTMENT OF COMMERCE

National Institute of Standards and Technology


Announcement of a Public Workshop Regarding Conformity Assessment 
Bodies for the Medicare Devices Annex of the US/EC Mutual Recognition 
Agreement

AGENCY: National Institute of Standards and Technology, DOC.

ACTION: Notice of public meeting.

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SUMMARY: The National Institute of Standards and Technology, (NIST) 
invites interested parties to attend a half-day workdshop for the 
development of requirements for a sub-program under the National 
Voluntary Conformity Assessment System Evaluation (NVCASE) Program. The 
sub-program will satisfy the product testing and quality system 
registration requirements of the Medical Devices Annex of the United 
States/European Commission Mutual Recognition Agreement. NVCASE 
procedures require NIST to consult the public establishing requirements 
to be applied in evaluations conducted within the scope of NVCASE 
programs. NIST, Food and Drug Administration (FDA), and European 
Commission (EC) personnel will participate in this workshop. There is 
no fee for the workshop; however, all attendees must register in 
advance with the Conformity Assessment Body Response Manager no later 
than April 2, 1999.

DATES: The NVCASE workshop will be held on April 15, 1999, from 9:00 
a.m. to 12:00 p.m.

ADDRESSES: The workshop will be held at the National Institute of 
Standards and Technology in the Red Auditorium, Administration 
Building, located at 100 Bureau Drive, Gaithersburg, MD 20899.

FOR FURTHER INFORMATION CONTACT: For further information, you may 
telephone [phone]. You may register for the workshop by E-mail at 
[e-mail] or by fax at 301-975-5414. You may also register by U.S. 
mail addressed to Conformity Assessment Body Response Manager, NIST, 
100 Bureau Drive, Stop 2100, Gaithersburg, MD 20899-2100.

SUPPLEMENTARY INFORMATION: In accordance with Title 15 Part 286.2(b) of 
the Code of Federal Regulations, NIST has established this program 
pursuant to a written request from a U.S. Government Agency, the Food 
and Drug Administration, in a letter dated March 1, 1998. The FDA 
announced their intend to use NIST NVCASE program for the Medical 
Devices Annex of the US/EC Mutual Recognition Agreement in the Federal 
Register on July 2, 1998 (63 FR 36247-36248.
    The NVCASE regulations found at 15 CFR Part 286 require NIST to 
consult the public when establishing requirements to be applied in 
evaluations conducted within the scope of NVCASE programs. This program 
under NVCASE will allow U.S. bodies to satisfy the conformity 
assessment requirements of the Medical Devices Annex of the US/EC 
Mutual Recognition Agreement.
    The NVCASE public workshop will follow the European Commission 
training workshop for Conformity Assessment Bodies in which EC 
personnel will outline the requirements of the Medical Devices Annex of 
the MRA. NIST, FDA and EC personnel will participate in this public 
workshop. Both NVCASE and EC training workshops will be held at the 
same location. The text of the US/EC MRA for the Medical Devices 
sectoral annex can be accessed on the Internet at http://
www.iep.doc.gov/mra/mra.htm.

    Dated: February 25, 1999.
Karen H. Brown,
Deputy Director.
[FR Doc. 99-5385 Filed 3-3-99; 8:45 am]
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