FDA Brief: Week of Feb 15, 2016
Final Order for Dignicap Classification Order
- Dignicap scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia approved on Dec 2015 (https://www.druganddevicedigest.com/2015/12/14/fda-brief-week-of-dec-7th-2015/
- Target Health, Inc. (on behalf of Dignitana AB)submitted a request for classification for class II
- FDA approved Class II with the establishment of special controls for reasonable assurance of effectiveness and safety
- Final order requires any firm submitting 510(k) for a similar device will need to comply with the special controls identified in the Order
- Identified Risks : Thermal Tissue Damage, Electromagnetic Interference/Electrical Shock, Adverse Tissue Reaction, Increased Risk of Scalp Metastases, Use Error, Scalp Pain, Headache, and Chills
- Special Controls: Non-clinical Performance Testing, Software Verification, Hazard Analysis, Electromagnetic Compatibility, Electrical testing, Biocompatibilty and Labeling
Premarket Approval (PMA) Required for Hip Joint Systems
- For hip joint metal/metal semi-constrained with (1) cemented acetabular component or (2) semi-constrained with an uncemented acetabular component.
- Remain Class III (higher risk) devices
- Rationale : Insufficient evidence and information to conclude that general controls in combination with special controls would provide reasonable assurance of the safety and effectiveness of these devices.
FDA based decision based on following activities:
- Working with the manufacturers
- Supporting technology to improve image quality around metal implants
- Encouraging metal ion test labs in trace element proficiency testing program
- Continuing review of published literature, Medical Device Reports
- Launching collaborative International Consortium of Orthopaedic Registries (ICOR)
- Requesting and reviewing device retrieval analyses from manufacturers
- Pursuing global collaborations to fully understand postmarket performance
- Issued Safety Communication to patients and health care providers
- Issued proposed order to submit premarket approval (PMA) applications.
- Convened Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee to seek expert scientific and clinical opinion