- Blood Glucose Monitoring Test Systems for Prescription Point-Of-Care Use - Draft Guidance for Industry and Food and Drug Administration Staff
- Self-Monitoring Blood Glucose Test Systems for Over-The-Counter Use - Draft Guidance for Industry and Food and Drug Administration Staff
- Guideline for Industry and Food and Drug Administration Staff - Class II Special Controls Guideline: Temporary Mandibular Condyle Reconstruction Plate
- Draft Guidance for Industry and FDA Staff - Commercially Distributed in Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Frequently Asked Questions
- Medical Device Development Tools - Draft Guidance for Industry, Tool Developers, and Food and Drug Administration Staff
- Design Considerations for Pivotal Clinical Investigations for Medical Devices - Guidance for Industry, Clinical Investigators, Institutional Review Boards and Food and Drug Administration Staff
- Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products - Draft Guidance for Industry and Food and Drug Administration Staff
- Ecopy Program for Medical Device Submissions - Guidance for Industry and Food and Drug Administration Staff
- Investigational Device Exemptions (IDES) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies - Guidance for Industry and Food and Drug Administration Staff
For more New FDA Guidance Documents, please see my previous blogs:
New Medical Device Guidelines for the 1st Quarter 2013
And to get the latest information for 2015:
New FDA Medical Device Guidance Documents for the 1st Quarter 2015
And to get the latest information for 2015:
New FDA Medical Device Guidance Documents for the 1st Quarter 2015