The European Commission has authorized the National Standards Authority of Ireland (NSAI) as the 11th notified body under the EU’s Medical Device Regulation.
Source: The GMP Letter
Category Archives: The GMP Letter
The UK government plans to update its regulatory framework for medical devices by the end of this year.
Source: The GMP Letter
The FDA clarified what information devicemakers should include in their 510(k) premarket submissions for peripheral vascular atherectomy devices in a new final guidance.
Source: The GMP Letter
The FDA cited six facilities for a variety of GMP lapses, including lax recordkeeping.
Source: The GMP Letter
Serious quality system deficiencies that were repeat violations from a 2015 inspection landed Korean devicemaker Won Industry an FDA warning letter following an inspection of its Siheung-si, South Korea facility.
Source: The GMP Letter
The FDA hit Phoenix, Arizona-based devicemaker CPAPNEA Medical Supply with a warning letter for marketing a device without premarket approval.
Source: The GMP Letter
Rhode Island device manufacturer Unetixs Vascular drew an FDA warning letter for failing to meet design requirements for its MultiLab Series ROODRA vascular diagnostic system.
Source: The GMP Letter
FDA Commissioner Stephen Hahn said that the agency is not aware of any medical device shortages connected to the outbreak of the novel coronavirus — but the agency is aware of 63 manufacturers representing 72 facilities in China that produce essential devices that are prone to potential shortage if there is a supply disruption.
Source: The GMP Letter
The FDA issued a new policy that will allow certain laboratories to use validated COVID-19 diagnostics while the agency reviews their Emergency Use Authorization (EUA) requests.
Source: The GMP Letter
The FDA will hold a March 5 workshop on evaluation practices for virtual and augmented reality in medicine at the agency’s White Oak Campus in Silver Spring, Maryland.
Source: The GMP Letter