HOW TO OBTAIN FORMS AND INSTRUCTIONS                            

Voluntary ( FDA 3500) form for reporting by health professionals :

•   By mail or fax : call 1‐800‐FDA‐1088 (fol low instructions for health professional or press "0" during the initial message )

•   By intern e t : www. f da.gov / medwatch (cl i ck on "How to Report " , then "Reporting by Health Professionals"). Print the form or download as a PDF file. There is also form software which can be downloaded and used to complete the forms using a personal computer. After the initial entries are m a d e, the completed form can be printed and mailed to FDA and/or the manufacture r. This software does not permit electronic submission of reports. If you prefer a copy of the free software on disk, call 1 ‐ 8 0 0 ‐ F DA‐1088 (press 0), or e‐mail MedWatch (medwatch @ bangate.fda.gov). Note: the form software contains both the FDA 3500 and the FDA 3500A forms.

Mandatory ( F DA 3500A) form for reporting by user facilities :

•   By mail or fa x : call 1‐800‐FDA‐1088 (press "0" during the initial message )

•   By intern e t : www.f da.gov (cl i ck on “Medical Dev i c e s / Radiological Health,” “ Program Are a s ,” “Medical Device Reporting,” and "Forms and Instructions." Print the form or download as a PDF file. There is also form software which can be downloaded and used to complete the forms using a personal c o m p u t e r. After the initial entries are made, the completed form can be printed and mailed to FDA and/ or the manufacturer. This software does not permit electronic submission of reports. If you prefer a copy of the free software on disk, call 1‐800‐FDA‐1088 (press 0), or e‐mail MedWatch ( medwatch @ b a n gat e. f d a . gov). Note: the form software contains both the FDA 3500 and the F DA 3500A forms .

HOW TO REPORT TO FDA

Voluntary (3500):

•   By mail (postage‐paid form) Med Watch

The FDA Medical Products Reporting Program

Food and Drug Administration 5600 Fishers Lane

Rockville, MD 20852‐9787

•  By phone: 1‐800‐FDA‐1088

•  By fax: 1‐800‐FDA‐0178

•   By internet: available late 1997

Mandatory (3500A):

•   By mail:

FDA Center for Devices & Radiological Health MDR Reporting

PO Box 3002

Rockville, MD 20847‐3002

Mark the envelope: "User Facility Report"

QUESTIONS ABOUT REPORTING?

Voluntary:     Contact the MedWatch office

Phone: 1‐800‐FDA‐1088 (press 0) or (301) 443‐0117 (local) Fax: 1‐800‐FDA‐0178 or (301) 443‐5776 (local)

E‐mail: medwatch@bangate.fda.gov Mail:      MedWatch

FDA, HF‐2

5600 Fishers Lane, Room 9‐57 Rockville, MD 20857

Mandatory:   Reporting Systems & Monitoring Branch (HFZ‐533)

FDA, CDRH

1350 Piccard Drive Rockville, MD 20850

Phone numbers for specific questions (Please use fax numbers except for emergencies): Interpretation of policy (301) 827‐0038 (fax) (301) 594‐2735 (voice)

Individual 3500A or semi‐annual reports

(301) 827‐0038 (fax) (301) 594‐2731 (voice)

Emergencies outside of normal East Coast business hours

(301) 443‐1240 (fax) (301) 443‐3757 (voice ‐ 24 hours/day)