[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
