Minutes of Institutional Review Board (IRB) Meetings

… III. DISCUSSION IRBs have been cited in OHRP Determination Letters 1 and FDA Warning Letters 2 for failing to prepare and maintain … website and can be viewed by the date issued. 2. FDA Warning Letters are posted on the FDA.gov website and can be …

Determination of Intended Use for 510(k) Devices - Guidance for CDRH Staff (Update to K98-1)

… the standardized language provided in the boilerplate letters 3 or may include other labeling limitations specific …

Guidance for Industry: Food Security Preventive Measures Guidance for Food Producers, Processors, and Transporters

… federal government's focal point for threat assessment, warning, investigation, and response for threats or attacks … the NIPC identifies credible threats and crafts specific warning messages to the food industry. Further information is … that are contained in purchase and shipping contracts or letters of credit, or using a vendor approval program) …

Small Entity Compliance Guide: Juice HACCP

… government requesting initiation of the MOU process. Letters to establish MOUs for juice should be submitted to: … be heat treated to destroy pathogens. 55. May I use the warning label statement on my products in lieu of … a HACCP system? Generally speaking, use of the juice label warning statement is not an alternative to compliance with …

Thermal Endometrial Ablation Devices (Submission Guidance for an IDE)

… necessary for any assembly/disassembly. Also, include a warning that the device should be thoroughly cleaned and … , pp.422-424. Treatment of dysfunctional uterine bleeding (letters) (1995) British Medical Journal, 310 (9982), …

Guidance for Industry: Questions and Answers on Juice HACCP Regulation

… government requesting initiation of the MOU process. Letters to establish MOUs for juice should be submitted to: … be heat treated to destroy pathogens. 63. May I use the warning label statement on my products in lieu of … a HACCP system? Generally speaking, use of the juice label warning statement is not an alternative to compliance with …

CPG Sec 110.310 Prior Notice of Imported Food Under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002

… FDA may elect to refuse prior notices or send Compliance letters to give the responsible parties warning prior to pursuing other regulatory actions, e.g., …

Guidance on the Content and Organization of a Premarket Notification for a Medical Laser

… should be noted. Provide a complete name and identifying letters and numbers for the standard, including the year of … steps that should be taken should they occur. Include any warning when there is reasonable evidence of an association …

Guidance Document For Nonprescription Sunglasses - Guidance for Industry

… labeling and advertising from several manufacturers. Warning letters have been issued by FDA to manufacturers advising …

Checklist of Information Usually Submitted in an Investigational Device Exemptions (IDE) Application for Refractive Surgery Lasers [excimer]

… onset of haze beyond 6 months with loss of 2 lines (10 letters) or more BSCVA J. Decrease in BSCVA of >10 letters not due to irregular astigmatism as shown by hard … away from other electrical medical devices and provide a warning in all labeling that the effects of the laser on …

Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers

… Control Devices Branch before responding to deficiency letters to clarify or discuss the deficiencies. Within 30 … following information: 1) potential safety hazards, e.g., "Warning, Toxic Strips. Contain the following chemicals:…" and …

Guidance for Industry: Juice Hazard Analysis Critical Control Point Hazards and Controls Guidance, First Edition

… labeling regulation in 21 CFR 101.17(g) that requires a warning statement on packaged fruit and vegetable juice … HACCP regulation such as effective dates, use of the label warning statement, and training. Additional information on … individuals. 6 In the January 22, and January 25, 2002 letters, FDA described high degree Brix juice concentrate as …