Soft (Hydrophilic) Daily Wear Contact Lenses – Performance Criteria for Safety and Performance Based Pathway
Posts tagged as “Draft Guidance”
UPDATE: The FDA recommends performing contained morcellation in women when laparoscopic power morcellation is appropriate Draft guidance – Product Labeling for Laparoscopic Power Morcellators
FDA Issues Draft Guidance on Arthroscopy Pump Tubing Sets
Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters – Premarket Notification (510(k)) Submissions
IVD companion diagnostics – Guidance on proposed regulatory requirements
Magnetic Resonance (MR) Coil – Performance Criteria for Safety and Performance Based Pathway
Breast Implants – Certain Labeling Recommendations to Improve Patient Communication
CDRH Proposed Guidances for Fiscal Year 2020 (FY 2020)
IMDRF Principles and Practices for Medical Device Cybersecurity
Providing Regulatory Submissions for Medical Devices in Electronic Format – Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act