[Federal Register: June 22, 1999 (Volume 64, Number 119)]
[Notices]               
[Page 33309]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr22jn99-101]                         


[[Page 33309]]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

 
Registration and Listing Grassroots Meeting for Medical Device 
Manufacturers

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of meeting.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the 
following meeting: Registration and Listing Grassroots Meeting for 
Medical Device Manufacturers. The topic to be discussed is FDA's 
intention to propose changes to the current medical device registration 
and listing process. This meeting is 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: The meeting will be held on July 15, 1999, 8:30 a.m. to 12 m.; 
registration will begin at 8 a.m.

ADDRESSES: The meeting will be held at the Holiday Inn Minneapolis West 
(Calhoun Ballroom), 9970 Wayzata Blvd., St. Louis Park, MN, 612-593-
1918, FAX 612-593-0150.

FOR FURTHER INFORMATION CONTACT: Bryan H. Benesch, Office of Health and 
Industry Programs (HFZ-220), Center for Devices and Radiological 
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD 
20850, 301-443-6597 ext. 131, e-mail ``BHB@CDRH.FDA.GOV''.
    For registration information: Rhonda L. Mecl, Supervisory 
Investigator, Minneapolis District Office, Food and Drug 
Administration, 240 Hennepin Ave., Minneapolis, MN 55401-1912, FAX 612-
334-4134.
    Those persons interested in attending the meeting should fax their 
registration including name, title, firm name, address, telephone, and 
fax number. There is no charge to attend this meeting, but advance 
registration is requested due to limited seating. If you need special 
accommodations due to a disability, please contact Rhonda L. Mecl 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. This meeting will help FDA obtain 
the medical device industry perspective on the changes under 
consideration and suggestions for additional changes. FDA has held 
three meetings on the same subject on April 20 and 21, 1999, in 
California (64 FR 12813, March 15, 1999) and on May 25, 1999, in 
Rockville, MD (64 FR 20006, April 23, 1999).
    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 meeting will be available on CDRH's 
Registration and Listing Process Reengineering Team website 
approximately 20 working days after the meeting. The CDRH Registration 
and Listing Process Reengineering Team home page may be accessed at 
``http://www.fda.gov/cdrh/grassroots/reglist.htm''.

    Dated: June 13, 1999.
 Linda S. Kahan,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-15756 Filed 6-21-99; 8:45 am]
BILLING CODE 4160-01-F