Blog Category: Medical Device

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...

FDA, MHRA Continues to Facilitate Access to Ventilators Supply

March 30, 2020
Food

As hospitals are in need of mechanical ventilation for an influx of patients due to coronavirus disease 2019 (COVID-19), regulatory bodies including the US Food and Drug Administration (FDA) and the...

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The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released new draft guidance to support firms planning to submit a 510(k) using the Safety and Performance...

FDA Bans Electrical Stimulation Devices Used for Self-injurious Behavior or Aggressive Behaviour

March 17, 2020
Medical Device

The US Food and Drug Administration (FDA) announced to ban electrical stimulation devices (ESDs) used to treat aggressive behaviour or self-injurious, denoting the third time in the agency’s history...