Meetings: Medical device quality systems inspection technique; FDA/industry exchange workshop,

[Federal Register: November 15, 1999 (Volume 64, Number 219)]

[Notices]

[Page 61878-61880]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr15no99-87]

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Food and Drug Administration/Industry Exchange Workshop on Medical Device Quality Systems Inspection Technique (QSIT); Public Workshops; Addendum

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

SUMMARY: The Food and Drug Administration (FDA), is announcing additional workshops in the series of FDA/Industry Exchange Workshops. The original list of workshops was published in the Federal Register of September 10, 1999. Topics for discussion at these workshops include: Development of QSIT, Compliance Program and Warning Letter (Pilot), Management Controls, Corrective and Preventive Action, Design Controls, and Industry Perspective of QSIT. These additional workshops will enhance the medical device community's understanding of QSIT, and the device industry's establishment of effective quality systems, thereby preventing regulatory problems during inspections.

Date, Time, and Location: See Table 1 in the Supplementary Information section of this document.

Registration: Send registration information (including name, title, firm name, address, telephone, and fax number) along with the correct payment amount to the Registrar. Fees cover refreshments, organization and site costs, and materials. Because space is limited, interested parties are encouraged to register early. Please arrive early to ensure prompt registration. If you need special accommodations due to a disability, please inform the Registrar at least 7 days in advance of the workshop. A sample registration form is provided at the end of this document.

Contact Person: Herman B. Janiger, Food and Drug Administration, Northeast Region, (HFRNE-17), 850 Third Ave., Brooklyn, New York 11232, 718-340-7000 ext. 5528. SUPPLEMENTARY INFORMATION:

In the fall of 1999, FDA field offices will begin using the QSIT nationwide as

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the primary tool for medical device inspections. QSIT was developed using a collaborative effort with stakeholders and was tested in the three districts. The additional workshops are scheduled as follows:

Table 1.

Deadline to Register Registrar and Workshop Address Date and Local Time

and Fee

Cosponsor

FDA Contact Person

Costa Mesa: Wyndham Tuesday, November 16, Friday, November 12, PeriAnn DiRocco, Marcia Madrigal, Garden Hotel at

1999, 8:30 a.m. to 1999, $90.00

Orange Country

Small Business Orange County

4:30 p.m.

Regulatory Affairs Representative, Airport, 3350 Avenue

Discussion Group Pacific Regional of the Arts, Costa

(OCRA), PMB 624, Office, 510-637- Mesa, CA 92626, 714-

5405 Alton Pkwy. 5A, 3980. 751-5100.

Irvine CA 92604- 3718, Phone/FAX 949- 348-9141, e-mail Sdirocco@aol.com. Irvine: Hilton Orange Wednesday, November Friday, November 12, PeriAnn DiRocco, Marcia Madrigal, County Airport,

17, 1999 8:30 a.m. 1999 $90.00

Orange Country

Small Business 18800 MacArthur

to 4:30 p.m.

Regulatory Affairs Representative, Blvd., Irvine, CA

Discussion Group Pacific Regional 92612, 949-833-9999

(OCRA), PMB 624, Office, 510-637- 5405 Alton Pkwy. 5A, 3980. Irvine CA 92604- 3718, Phone/FAX 949- 348-9141, e-mail Sdirocco@aol.com.

The above workshops further implement the FDA Plan for Statutory Compliance (developed under section 406 of the FDA Modernization Act (21 U.S.C. 393)) by working more closely with stakeholders and ensuring access to needed scientific and technical expertise. They also comply with the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121), which requires outreach activities by Government agencies directed to small businesses. This notice announcing the workshops and a registration form may be accessed at the CDRH website at http:// www.fda.gov/cdrh/fedregin.html. The following information is requested for registration:

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[GRAPHIC] [TIFF OMITTED] TN15NO99.022

Dated: November 5, 1999. Margaret M. Dotzel, Acting Associate Commissioner for Policy.

[FR Doc. 99-29630Filed11-12-99; 8:45 am]

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