[Federal Register Volume 64, Number 49 (Monday, March 15, 1999)]
[Notices]
[Pages 12813-12814]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-6265]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Registration and Listing Grassroots Meetings for Medical Device
Manufacturers
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of meetings.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
following two open public meetings: Registration and Listing Grassroots
Meetings. The topic to be discussed at these meetings is FDA's
intention to propose changes to the current medical device registration
and listing system. These meetings are being conducted to provide a
forum in which FDA can obtain industry views on changes to the device
registration and listing system that FDA is currently considering. The
changes being considered are aimed at streamlining the collection of
registration and listing data, improving the accuracy and quality of
the data in the system, and decreasing the time it takes manufacturers
to register their establishments and list their devices, while
ultimately reducing FDA's cost of maintaining the registration and
listing system.
DATES: See Table 1 in the ``SUPPLEMENTARY INFORMATION'' section of this
document.
ADDRESSES: See Table 1 in the ``SUPPLEMENTARY INFORMATION'' section of
this document.
FOR FURTHER INFORMATION CONTACT:
For general meeting program information: Bonnie H. Malkin, Office
of Health and Industry Programs (HFZ-200), Center for Devices and
Radiological Health, Food and Drug Administration, 1350 Piccard Dr.,
Rockville, MD 20850, 301-443-2845.
For registration information: Mark S. Roh, Pacific Region, Food
and Drug Administration, 1301 Clay St., suite 1180N, Oakland, CA 94612-
5217, (FAX) 510-637-3977.
Those persons interested in attending these meetings, should fax
their registration to 510-637-3977, including name and position/title,
company name, mailing address, and telephone and fax numbers. There is
no charge to attend these meetings, but advance registration is
requested due to limited seating. If you need special accommodations
due to a disability, please contact Mark S. Roh at least 7 days in
advance.
SUPPLEMENTARY INFORMATION: Over the past one and a half years, FDA has
reviewed the entire registration and listing process to determine if
the process can be made more efficient and accurate. This was one of
many reengineering efforts conducted by the Center for Devices and
Radiological Health (CDRH). This reengineering effort has resulted in a
number of suggestions aimed at improving the registration and listing
process for both FDA and industry. These meetings will help FDA obtain
the medical device industry perspective on the changes under
consideration and suggestions for additional changes.
Some of the changes that FDA is currently considering include the
following:
(1) Require industry submission of registration and listing
information through the World Wide Web (WEB). What are the advantages
and disadvantages to industry and how would industry be affected if WEB
submissions were mandated?
(2) Require that owners and parent companies register and list and
take responsibility for the registration and listing of their
establishments. What is the highest level in a company that should be
responsible for registration and listing and how should this level be
defined/described?
(3) Require that additional data elements be submitted to FDA,
e.g., premarket submission numbers for those devices that have gone
through the premarket notification (510(k)), premarket approval, or
product development protocol process.
(4) Because of the ease of submission through the WEB, require
that firms register and list within 5 days (current requirement is 30
days) of entering into an operation that requires registration and
listing.
A summary report of the meetings will be available on the CDRH
website approximately 15 working days after the meetings. The CDRH home
page may be accessed at ``http://www.fda.gov/cdrh'' .
Table 1.--Meeting Schedules
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Meeting Address Dates Times
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Northern California Meeting .................................... ....................................
Airport Hyatt, San Jose, 1740 Tuesday, April 20, 1999 Registration: 7:30 a.m.
North First St., San Jose, CA Meeting: 8:30 a.m. to 12 m.
95112, 408-993-1234.
Southern California Meeting .................................... ....................................
FDA Los Angeles District Office, Wednesday, April 21, 1999 Registration: 7:30 a.m.
19900 MacArthur Blvd., suite 300, Meeting: 8:30 a.m. to 12 m.
Irvine, CA 92612, 949-798-7714.
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[[Page 12814]]
Dated: March 9, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-6265 Filed 3-12-99; 8:45 am]
BILLING CODE 4160-01-F
