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Titles
- Antimicrobial susceptibility test (AST) system devices: updating breakpoints in device labeling : guidance for industry and Food and Drug Administration staff1
- Breast implants: certain labeling recommendations to improve patient communication : guidance for industry and Food and Drug Administration staff1
- Clear liquids may place patients at risk1
- Collaborative patient safety effort: addressing phlebotomy specimen mislabeling1
- Dangers associated with unlabeled basins, bowls, and cups1
- Enforcement policy regarding use of National Health Related Item Code and National Drug Code numbers on device labels and packages: guidance for industry and Food and Drug Administration staff1
- Enforcement policy regarding use of national health related item code and national drug code numbers on device labels and packages: guidance for industry and Food and Drug Administration Staff1
- Enforcement policy--OTC sunscreen drug products marketed without an approved application1
- Enforcement priorities for electronic nicotine delivery systems (ENDS) and other deemed products on the market without premarket authorization1
- FDA oversight of tobacco manufacturing establishments1
- Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry1
- Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff1
- Instructions for use: patient labeling for human prescription drug and biological products : content and format1
- Laser products: conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 : (Laser Notice No. 56) : guidance for industry and Food and Drug Administration staff1
- Medical devices: cancer risk led FDA to warn against certain uses of power morcellators and recommend new labeling : report to Congressional requesters1
- Mix-up between skin prep solution and adhesive remover1
- Product labeling for laparoscopic power morcellators: guidance for industry and Food and Drug Administration staff1
- Submission of plans for cigarette packages and cigarette advertisements (revised)1
- Surgical staplers and staples for internal use: labeling recommendations : guidance for industry and Food and Drug Administration staff1
- Testing and labeling medical devices for safety in the magnetic resonance (MR) environment: guidance for industry and Food and Drug Administration staff1