[Federal Register Volume 64, Number 78 (Friday, April 23, 1999)]
[Notices]
[Page 20006]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-10140]



[[Page 20006]]

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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 May 25, 1999, 8:30 a.m. to 12 noon; 
registration will begin at 7:30 a.m.

ADDRESSES: The meeting will be held at 9200 Corporate Blvd., rm. 20B, 
Rockville, MD 20850.

FOR FURTHER INFORMATION CONTACT: Bryan H. Benesch, Food and Drug 
Administration, Center for Devices and Radiological Health, Office of 
Health and Industry Programs (HFZ-220), 1350 Piccard Dr., Rockville, MD 
20850, 301-443-6597 ext. 131, (FAX) 301-443-8810, (e-mail) 
``[email protected]''.
     Those persons interested in attending the meeting should fax or e-
mail 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 Bryan 
H. Benesch 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 announced 
two meetings on the same subject to be held April 20, 1999, in 
California (64 FR 12813, March 15, 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, 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 
website approximately 15 working days after the meeting. The CDRH home 
page may be accessed at ``http://www.fda.gov/cdrh''.

    Dated: April 19, 1999.
William K. Hubbard,
Acting Deputy Commissioner for Policy.
[FR Doc. 99-10140 Filed 4-22-99; 8:45 am]
BILLING CODE 4160-01-F