[Federal Register: March 15, 1999 (Volume 64, Number 49)] [Notices] [Page 12813-12814] From the Federal Register Online via GPO Access [wais.access.gpo.gov] [DOCID:fr15mr99-47] ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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 ---------------------------------------------------------------------------------------------------------------- Meeting Address Dates Times ---------------------------------------------------------------------------------------------------------------- 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. ---------------------------------------------------------------------------------------------------------------- [[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