- Mobile Medical Applications - Guidance for Industry and Food and Drug Administration Staff
- Global Unique Device Identification Database (GUDID) - Draft Guidance for Industry
- Select Updates for Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems - Draft Guidance for Industry and Food and Drug Administration Staff
- The Applicability of Good Laboratory Practice in Premarket Device Submissions: Questions and Answers - Draft Guidance for Industry and Food and Drug Administration Staff
- IRB Responsibilities for Reviewing the Qualifications of Investigators, Adequacy of Research Sites, and the Determination of Whether an IND/IDE is Needed
- Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and Food and Drug Administration Staff
- Guidance for Industry - Oversight of Clinical Investigations - A Risk-Based Approach to Monitoring
- Minimizing Risk for Children's Toy Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff
- Guidance for Industry and Food and Drug Administration Staff and Foreign Governments - FY 2014 Medical Device User Fee Small Business Qualification and Certification
- Draft Guidance for Industry and Food and Drug Administration Staff - Medical Device Reporting for Manufacturers
You may want to review my two previous blogs on New FDA Guidance Documents:
I also have provided more information on the new UDI Unique Device Identifier system at StandardsForum.com. And you can find the compliance dates for this new regulation at this earlier Document Center Blog: Compliance Dates for the FDA UDI Ruling.
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
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