FDA Revises Guidance on 510(k)s for Atherectomy Devices
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
483 Roundup: Six Devicemakers Cited for GMP Violations
The FDA cited six facilities for a variety of GMP lapses, including lax recordkeeping. Source: The GMP Letter
Korean Facility Warned for Repeat Violations
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.…
Mask Maker Warned for Unapproved Device
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 Firm Draws Warning for Design Controls
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
No Reported Device Shortages From Coronavirus Outbreak, FDA Says
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…
FDA Allows Early Release of COVID-19 Diagnostics
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
WHO Considers Unit-Level Serial Numbers for Drug Tracking
The World Health Organization (WHO) is seeking comments by February 28 on a draft policy on tracking and tracing drugs through the supply chain that would push globally for unit-level…
483 Roundup: FDA Cites Seven Firms for GMP, Quality Lapses
The FDA hit drugmakers in China, South Korea, India and Germany for numerous GMP and other violations observed during agency inspections. Source: Drug GMP Report
Warning Letters: FDA Warns Drugmakers in China and Germany
The FDA issued warning letters to drug manufacturing facilities in China and Germany for lax testing, recordkeeping and other failures. Source: Drug GMP Report