Category: Medical Device

Medical Device Labeling under FDA

March 23, 2021
Medical Device

Food and Drug Administration (FDA) puts forth certain regulations in the U.S. that are abiding on food, drugs, medical devices, biologics, cosmetics and even radiation emitting electronic products....

FDA Labeling Requirements, Labeling requirements for Medical Devices, Medical Device Labeling, medical device labeling requirements, medical device labels, Medical device regulatory requirements

EU Regulations: Things Still to be known

February 22, 2021
Medical Device

Medical Device Regulations (EU) 2017/745 is an advancement that would help EU in coping with medical science changes. Manufacturers will regard the new regulations as a benchmark globally as it would...

FDA Issues New Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers during COVID-19 Emergency

April 2, 2020
Medical Device

FDA issued this guidance to provide a policy to help expand the availability and capability of sterilizers, disinfectant devices, and air purifiers during this public health emergency. The Agency...

Medical Device Change Control Process

March 30, 2020
Medical Device

Globalization of the market has greatly enhanced competition and pressure on manufacturers to develop new and high-quality products faster at a low cost. To stay competitive, manufacturers should be...

Danish Medicines Agency: Newly Improved Reporting Requirement to Strengthen the Surveillance of Medical Devices

March 17, 2020
Medical Device

The Danish Medicines Agency recommended newly enhanced reporting requirements on medical devices to ensure that the surveillance of medical devices becomes more focused for the benefit of patients. This...

USA: CDRH drafts Guidance on Contact Lenses – Performance Criteria to Support 510(k)s

March 17, 2020
Medical Device

The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released new draft guidance to support firms planning to submit a 510(k) using the Safety and Performance...