Is reporting to MedWatch mandatory?

The regulation specified that reports be filed on the FDA’s Medwatch Form 3500A or an electronic equivalent. Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury.

Is Oregon a mandatory reporting state?

Who is a mandatory reporter? All “public or private officials,” including employees of Oregon State University, are mandatory reporters. Under state law, the following types of individuals are included: School employees, including an employees of a higher education institution.

How to report an adverse event to MedWatch?

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, For use by healthcare professionals, consumers, and patients.

When to report to the Oregon Health Authority?

Starting October 1, 2020: Providers are required to collect and report on expanded race, ethnicity, language and disability (REALD) data for all COVID-19 encounters using this reporting portal. Our reporting form is available as a fillable PDF if you prefer to traditionally report to your Local Public Health Authority.

How to contact the FDA’s MedWatch program?

MedWatch, the FDA’s medical product safety reporting program for health professionals, patients and consumers. Contact Number 1-888-INFO-FDA (1-888-463-6332)

Where to find mandatory reporting information in Oregon?

Mandatory reporting information for other professions can be found under the specific topics on the Mandatory Reporting Web page. As an employee of the Oregon Department of Human Services (ODHS) you are a Mandatory Reporter.