FDA / Regulatory News
More device designations and approvals using FDA’s Breakthrough Devices Program (Novel Technology)
Final Guidance published Dec 2018, First Approval Dec 2017, so far 199 designations / 12 approvals total
2 Steps to qualify for the Program:
- “Yes” for: Does the device provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or condition?
- And “Yes” for one of the questions:
- Do approved or cleared alternatives exist?
- Does the device offer significant advantages over approved/cleared alternatives
- Is availability of the device in the best interest of patients?
2019 recent breakthrough designations (examples):
- Liberate Medical, LLC for VentFree to stimulate the respiration of patients who are on mechanical ventilators for >4 days
- Fujirebio Diagnostics, Inc. for Lumipulse ® G B-Amyloid Ratio (1-42/1-40) Quantitative IVD as a diagnostic tool in the fight against Alzheimer’s Disease
Benefits of the Program:
- Enhanced support and guidance from FDA
- Prioritized review and approvals
Information Systems Security / Data Privacy
DNA testing startup Veritas Genetics confirms data breach
DNA testing startup, has said a data breach resulted in unauthorized access of some customer information.
Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks – An unauthorized person (someone other than a patient, patient caregiver, or health care provider) could potentially record and replay the wireless communication between the remote and the MiniMed insulin pump. Using specialized equipment, an unauthorized person could instruct the pump to either over-deliver insulin to a patient, leading to low blood sugar (hypoglycemia), or stop insulin delivery, leading to high blood sugar and diabetic ketoacidosis, even death. To date, the FDA is not aware of any reports of patient harm related to these potential cybersecurity risks.
Product Recalls
Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System – Zimmer Biomet recalled the ROSA Brain Device due to a software issue with ROSA Brain v3.0.0.0 (v3.0.0.16 software) and ROSA Brain v3.0.0.5 (v3.0.0.20 software, collectively referred to as v3.0 software), which can drive the robotic arm to an incorrect position resulting in risks for the patient. Zimmer Biomet has received five complaints related to this issue, including one patient injury. No deaths related to this issue have been reported.
