Resources for Compliance With SMDA
* Medical Device Reporting under SMDA. A comprehensive guide offering tips on implementation, analysis of the regulation, copies of the rules, sample policies and procedures, reporting forms and tools, risk management checklists, incident investigation techniques and tools, and handouts for staff development and training. The cost is $245. Contact: ECRI, 5200 Butler Pike, Plymouth Meeting, PA, 19462-1298. Telephone: (610) 825-6000.
* U.S. Food and Drug Administration (FDA) MedWatch Forms (No. 3500A), Semiannual Reporting Forms (No. 3419). Consolidated Forms and Publications Office, Washington Commerce Center, 3222 Hubbard Road, Landover, MD 20785. Telephone: (800) FDA-1088. Or, order these documents through an automated fax system, 24 hours a day, seven days a week, by dialing (800) 899-0381.
Or, access these and other "Facts-On-Demand" related to medical device reporting by dialing the above fax number, pressing "1" at the initial voice prompt, "2" at the second voice prompt, and then entering the three-digit "shelf number" for the document(s) you want. Federal Register, Final Rule (Docket 91N-0295), shelf number 336; Baseline Report, Form FDA 3417, shelf number 407; Annual Certification, Form FDA 3381, shelf number 408; Semi-Annual Report, Form FDA 3419, shelf number 409; Instructions for Completing FDA Form 3500A with Coding Manual, shelf number 853; MedWatch FDA Form 3500A, shelf number 854.
* Continuing Care Risk Management Program, ECRI, Plymouth Meeting, PA. Program to assist in compliance with SMDA regulations. Includes instructional binders, self-assessment questionnaires, telephone consultation, and on-line services, including the computerized reporting system for SMDA compliance. Electronic filing service for semiannual SMDA reporting included. Telephone: (610) 825-6000; ask for Amy Goldberg-Alberts, risk management.
* Health Devices Alerts Data Base. World's largest database on medical device problems, hazards, and recalls. Available on-line, and on CD-ROM. Specialized searches also available. Telephone: Eileen Erinoff, (610) 825-6000.
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