In Vitro Diagnostic Devices: Guidance for the Preparation of 510(k) Submissions - Appendix D - CDRH Document Retrieval Systems

 IVD Manual Appendixes Index

APPENDIX D - CDRH DOCUMENT RETRIEVAL SYSTEMS

The Division of Small Manufacturers Assistance (DSMA)was mandated by the 1976 medical device legislation to provide technical assistance and regulatory guidance to manufacturers to help them comply with Food and Drug Administration (FDA) requirements for medical devices. DSMA is located in the Center for Devices and Radiological Health (CDRH) within FDA.

To contact DSMA staff for technical or regulatory assistance; call 800.638.2041 or 301.443.6597, fax 301.443.8818, E-mail DSMA@CDRH.FDA.GOV or write to the Division of Small Manufacturers Assistance (HFZ-220), Food and Drug Administration, 1350 Piccard Drive, Rockville, MD 20850-4307.

Manufacturers and others who are interested in the regulatory requirements for marketing medical devices and radiation-emitting electronic products can quickly obtain the latest information on operating policies and procedures through one of the following CDRH/DSMA document retrieval systems:

CDRH Facts-On-Demand - This automated system allows anyone to obtain CDRH information, 24 hours a day, 7 days a week by calling 800.899.0381 or 301.827.0111 from a touch-tone telephone. Using the telephone keypad and following the voice prompts, the caller can access the DSMA Facts section of CDRH Facts-On-Demand and request a DSMA Facts index or enter the three or four digit Shelf number for the document(s) they want. The DSMA Facts index & documents that are less than 30 pages are put in queue to be automatically faxed to the fax number provided by the requester. Documents that are greater than 29 pages are faxed after normal business hours.

World Wide Web ­ FDA/CDRH maintains an entry on the World Wide Web for easy access to information. Information includes text, graphics, and files that may be downloaded to a PC with access to the Web. Updated on a regular basis, the CDRH Home Page includes device safety alerts, Federal Register reprints, information on pre­market submissions (including lists of approved applications and manufacturers' addresses), small manufactures' assistance, information on video conferencing and electronic submissions, mammography matters, and other device­oriented information. The home page may be accessed via FDA's home page at http://www.fda.gov or directly at http://www.fda.gov/cdrh/index.html

A text­only version of the World Wide Web is also available from a computer or VT­100 compatible terminal by dialing 800­222­0185 (terminal settings are 8/1/N). Once the modem answers, press Enter several times and then select menu choice 1: FDA BULLETIN BOARD SERVICE. From there follow instructions for logging in, and at the BBS TOPICS PAGE, arrow down to the FDA Home Page (do not select the first CDRH entry). Then select Medical Devices and Radiological Health. From there select CENTER FOR DEVICES AND RADIOLOGICAL HEALTH for general information, or arrow down for specific topics.

DSMADOCs - Fax a request for the documents available in paper copy by mail to Gene Allen at 301.443.8818. Include the Shelf_# of the documents and your mailing address. Two separate complete indexes are available; 1. through CDRH Facts-On-Demand, or 2. by Fax order, as noted in the table below.