News
Accel Groups select ten medical devices or in vitro diagnostic reagents from the monthly 510(k) clearance list (five from Chinese manufacturers and five from foreign manufacturers) for brief introductions.
Roche's TAGS technology enables simultaneous detection of 12 respiratory viruses, including influenza A, influenza B, respiratory syncytial virus (RSV), and COVID-19.
On September 4, the FDA released a draft guidance that significantly revises its previous guidance on the use of voluntary patient preference information (PPI) in medical devices, shifting the focus from the premarket stage to the entire product lifecycle.
Accel Groups select ten medical devices or in vitro diagnostic reagents from the monthly 510(k) clearance list (five from Chinese manufacturers and five from foreign manufacturers) for brief introductions. This aims to provide the latest global updates on medium and low-risk devices or reagents.
FDA issued a draft guidance on August 22 detailing the types of modifications it considers suitable for inclusion in a Predetermined Change Control Plan (PCCP) and the information sponsors should include in their premarket approval (PMA), de novo, or 510(k) submissions to support their proposed PCCP.
FDA published the draft guidance "Dental Curing Lights - Premarket Notification (510(k)) Submissions - Draft Guidance for Industry and Food and Drug Administration Staff," on July 12, 2024, for feedback. Feedback needs to be submitted by September 10, 2024.
