FDA Seeks Input on Risk-Benefit Reviews for Weight Loss Devices
The FDA laid out its latest thinking on how it will handle risk-benefit reviews for weight-loss devices in a new discussion paper released ahead of planned draft guidance. Read More
FDA’s Guidance on Prostate Tissue Ablation Devices Called ‘Too Restrictive’
The FDA’s draft guidance on clinical testing for prostate tissue ablation devices is too restrictive, industry groups said in written comments to the agency. Read More
Devices News
CDRH Finalizes Recommendations on De Novo Requests
The FDA finalized three guidance documents related to de novo classification requests for clearance when there is no predicate device for comparison. Read More
FDA Issues Warning to Indiana Devicemaker
The FDA issued a warning letter to Polymer Technology Systems — doing business as PTS Diagnostics — arising from an inspection earlier this year of its facility in Indianapolis. Read More
CDRH Posts New Guidances on 510(k) Submissions
As part of its ongoing overhaul of the 510(k) process, CDRH released finalized guidances on its special 510(k) and abbreviated 510(k) programs, on its refuse-to-accept policy for 510(k)s and on formatting recommendations for submissions. Read More
483 Roundup: FDA Hits Three Firms for Quality Management Lapses
Lusys Laboratories: A 16-item Form 483 highlighted a litany of QMS lapses uncovered at Lusys Laboratories’ San Diego, California plant during a Jan. 22-Feb. 7 FDA inspection. Read More
