- Use of an Electronic Informed Consent in Clinical Investigations: Questions and Answers, 2015 Draft
- Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, 2015 Edition
- Procedures for Meetings of the Medical Devices Advisory Committee, 2015 Draft
- Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval, 2015 Edition
- Expedited Access for Premarket Approval and De Novo Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Diseases or Conditions, 2015 Edition
- Risk Evaluation and Mitigation Strategies: Modifications and Revisions, 2015 Edition
- Acceptance of Medical Device Clinical Data from Studies Conducted Outside the United States, 2015 Draft
- Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices, 2015 Draft
- Providing Regulatory Submissions in Electronic Format - Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications, Revision 3
- Patient Preference Information - Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Device Labeling, 2015 Draft
- Adaptive Designs for Medical Device Clinical Studies, 2015 Draft
- Class II Special Controls Guideline: Multiplex Nucleic Acid Assay for Identification of Microorganisms and Resistance Markers from Positive Blood Cultures, 2015 Edition
- Content and Format for Abbreviated 510(k)s for Early Growth Response 1 (EGR1) Gene Fluorescence In-Situ Hybridization (FISH) Test System for Specimen Characterization Devices, 2015 Edition
- Unique Device Identification: Direct Marking of Devices, 2015 Draft
- Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices, 2015 Draft
- Premarket Notification Requirements Concerning Gowns Intended for Use in Health Care Settings, 2015 Draft
You may also want to take a look at my previous post on this topic:
