[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] ----------------------------------------------------------------------- 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.
-----------------------------------------------------------------------
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 301-975-5120. You may register for the workshop by E-mail at scp@nist.gov 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 https:// 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] BILLING CODE 3510-13-M