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  • 2010 Form 3500a -- Submission Of Exemption Request - Justia

Get 2010 Form 3500a -- Submission Of Exemption Request - Justia

CALIFORNIA FORM Submission of Exemption Request 3500A Exemption Based on Internal Revenue Code (IRC) Section 501(c)(3) Federal Determination Letter Enclose a copy of the Federal Determination Letter.

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MedWatch is not only for medical professionals to report adverse events, but the public is also encouraged to report adverse events as well.

User facilities must report a medical device-related serious injury to the manufacturer, or to the FDA if the medical device manufacturer is unknown. User facilities must also submit annual reports to the FDA by January 1 of each year as described in 803.33.

If you need information or if you have questions or comments about a medical product, please call the FDA's toll-free information line, 1-888-INFO-FDA (1-888-463-6332) Press 2 to report into MedWatch or for instructions.

Reporting can be done through our online reporting portal or by downloading, completing and then submitting FDA Form 3500 (health professional) or 3500B (consumer/patient) to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.

All IND safety reports must be submitted on Form 3500A (if from clinical trials) or in a narrative format (if from animal or epidemiological studies) and be accompanied by Form 1571 (PDF - 830KB). The type of report (initial or follow-up) should be checked in the respective boxes on Forms 3500A and 1571.

Forms may be downloaded from our website at https://.fda.gov/safety/medical-product-safety-information/medwatch-forms-fda-safety-reporting and submitted by Fax or mail following the instructions; by completing and submitting forms online; or by calling FDA at 800-FDA-1088 (800-322-1088) and reporting by telephone.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
All Forms
Search all Forms
Industries
Forms in Spanish
Localized Forms
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232