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FDA Warns Manufacturers to Scrutinize Third-Party Testing Data

The U.S. Food and Drug Administration (FDA) is reminding medical device manufacturers to independently verify testing results generated by third parties that are included in premarket submissions to the agency.

Recognized Components and Ethical Compliance Obligations

This paper provides an overview on the importance of ethical obligations to help ensure end-product safety and its certifications effectively address and satisfy component level application considerations. These are known as “Conditions of Acceptability” for most North American certification reports and “Application Considerations” for most European Union certification authority reports.

FDA Updates 510(k) Third-Party Performance Metrics

The U.S. Food and Drug Administration (FDA) has published its most recent data on...

CPSC adopts third-party testing rules for children’s products

The U.S. Consumer Product Safety Commission (CPSC) has approved new third-party testing rules for...

Use of Third Party EMC or Radio Test Laboratories

There are numerous reasons for the use of an external test laboratory by organizations developing, manufacturing or marketing electric or electronic products. These reasons may include lack of or limited testing capability, scheduling conflicts within the organization, etc. Whatever the case may be, the proper selection of an external third party test laboratory is critical since the test results may be used to demonstrate product compliance or to verify changes to a product design.

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