Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis
You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments should with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document, contact Jeffrey Cooper, DVM at (301) 796-5590 or via email at email@example.com.
U.S. Department of Health and Human Services Food and Drug Administration Center for Devices and Radiological Health Office of Device Evaluation Division of Reproductive, Gastro-Renal, and Urological Devices Gastroenterology and Renal Devices Branch
Food and Drug Administration
Center for Devices and Radiological Health
Office of Device Evaluation
Division of Reproductive, Gastro-Renal, and Urological Devices
Gastroenterology and Renal Devices Branch
Additional copies are available from the Internet. You may also send an e-mail request to firstname.lastname@example.org to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number 1781 to identify the guidance you are requesting.
The use of applicable standards is encouraged. These could include:
ISO 594: Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
ISO 10555-1: Sterile, Single-use intravascular catheters - Part 1: General requirements (except for minimum force at break recommendation should be 10 pounds for polyurethane catheters due to the more frequent handling of hemodialysis catheters compared to general catheters, the great prevalence of polyurethane as the main material, and that polyurethane typically can support 50 lbs or more.)
FDA Blue Book Memorandum #G95-1, entitled Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing.
ISO 14971:2007 Medical Devices – Application of risk management to medical devices
12 CDRH has issued draft guidance on Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents. When finalized, this guidance will represent the Center's current thinking on this topic. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/ GuidanceDocuments/ucm071380.htm.
13 Final labeling must comply with the requirements of 21 CFR Part 801 and final labeling for prescription medical devices must comply with 21 CFR 801.109. Labeling recommendations in this guidance are consistent with the requirements of Part 801.