[Federal Register Volume 65, Number 159 (Wednesday, August 16, 2000)]
[Notices]
[Pages 49992-49993]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-20718]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Registration and Listing and MDR Baseline Reporting 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 and MDR 
Baseline Reporting Grassroots Meetings for Medical Device 
Establishments. The topics to be discussed are FDA's intention to 
propose changes to the current medical device registration and listing 
process, and Medical Device Reporting (MDR) baseline reporting process. 
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 establishments to register and list their 
devices, while ultimately reducing FDA's cost of maintaining the 
registration and listing system. Additional changes being considered 
are aimed at streamlining the collection of MDR baseline information by 
making this data a part of the device listing process, rather than the 
MDR data collection process.

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: Bryan H. Benesch, Office 
of Compliance (HFZ-300), Center for Devices and Radiological Health, 
Food and Drug Administration, 2094 Gaither Rd., Rockville, MD 20850, 
301-594-4699 ext. 122, FAX 301-594-4610, e-mail: [email protected].
    For registration information about the Dallas meeting: Ms. Melissa 
Crabtree, Food and Drug Administration, 7920 Elmbrook Rd., suite 102, 
Dallas, TX 75247-4982, FAX 214-655-8114.
    For registration information about the Irvine meeting: Ms. Marcia 
Madrigal, Pacific Region, Food and Drug Administration, 1301 Clay St., 
suite 1180N, Oakland, CA 94612-5217, FAX 510-637-3977.
    Persons interested in attending a meeting should fax their 
registration to either Ms. Crabtree (Dallas) or Ms. Madrigal (Irvine), 
including your name and position/title, firm name, address, telephone 
and fax number. There is no charge to attend either meeting, but 
advance registration is requested due to a maximum number of 65 
attendees per meeting; walk-in registrations may not be accommodated. 
If you need special accommodations due to a disability, please contact 
the appropriate person at least 7 days in advance.

SUPPLEMENTARY INFORMATION:
    Over the past 3 years, FDA has reviewed the entire registration and 
listing process to determine how 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. FDA has held four meetings on the same subject. 
These meetings took place on April 20 and 21, 1999, in California, May 
25, 1999, in Rockville, MD, and on July 15, 1999, in Minneapolis, MN.
    Some of the changes that FDA is currently considering include the 
following:
    (1) Require industry submission of registration and listing 
information through the CDRH Internet site. What are the advantages and 
disadvantages to industry, and how would industry be affected if 
Internet based submissions are mandated?
    (2) Require that parent companies register as establishments.
    (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)), humanitarian device 
exemption, premarket approval, or product development protocol 
processes.
    (4) Because of the ease of submission through the CDRH Internet 
site, 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 each meeting will be available on CDRH's 
Internet site approximately 60 working days after each meeting. The 
CDRH Registration and Listing Process Reengineering Team home page may 
be accessed at http://www.fda.gov/cdrh/grassroots/reglist.htm.
    The Office of Management and Budget (OMB) has requested FDA look at 
other options for the collection of the baseline data elements required 
by 21 CFR 803.55 of the Medical Device Reporting (MDR) regulation. This 
was, in part, initiated by letters from AdvaMed (formerly the Health 
Industry Manufacturers Association) pointing out some redundancies in 
information collection. Manufacturer baseline data are currently 
submitted to the FDA on Form 3417 and requests product information for 
the specific device. Some of these data elements are also collected 
under the Medical Device Registration and Listing regulation, 21 CFR 
part 807.
    FDA is considering requesting some data elements found on the 
baseline form through an Internet site interface that will allow the 
device industry to register and list electronically. In an effort to 
eliminate duplicative reporting and provide for a more efficient data

[[Page 49993]]

collection process, CDRH is exploring the idea that, for MDR purposes, 
model level device information could also be collected as part of the 
proposed registration and listing process. The authority to regulate 
the requirements imposed upon manufacturers who submit baseline reports 
would remain in Sec. 803.55.

                                           Table 1.--Meeting Schedules
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           Meeting Address                            Dates                                 Times
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Dallas Meeting, Radisson Hotel        Tuesday, September 19, 2000           Registration: 8 a.m.
 Dallas,1893 West Mockingbird Lane,                                           Meeting: 8:30 a.m. to 12:30 p.m.
 Dallas, TX 75235, 214-634-8850.
Irvine Meeting, Food and Drug         Wednesday, September 20, 2000         Registration: 8 a.m.
 Administration, Los Angeles                                                  Meeting: 8:30 a.m. to 12:30 p.m.
 District Office, 19900 MacArthur
 Blvd., suite 300, Irvine, CA 92612,
 949-798-7714.
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    Dated: August 10, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-20718 Filed 8-15-00; 8:45 am]
BILLING CODE 4160-01-F