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Draft Guidance for Industry and Food and Drug Administration Staff - Class II Special Controls Guidance Document: Implanted Blood Access Devices for Hemodialysis

Wed, 06/20/2012 - 5:30am
U.S. Food & Drug Administration

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draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.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 jeffrey.cooper@fda.hhs.gov.

CDRH Logo 

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

Preface

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to dsmica@fda.hhs.gov 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.


Standards

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


1 Format for Traditional and Abbreviated 510(k)s

2 Device Advice - Premarket Notification Submission 510(k)

3 The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications

4 A material designation number is a unique number assigned to a unique material or component. An example is polyurethane 2360-80A.

5 Draft Guidance for Industry and FDA Staff - Premarket Notification [510(k)] Submissions for Medical Devices that Include Antimicrobial Agents

6 Patients are exposed to hemodialysis catheter and shunt materials over a long period of time. A long-term (90 to 120 days) implantation study with histopathology may replace sub-chronic toxicity.

7 The priming volume is the amount of fluid required to fill the inside of the catheter from the hubs to the tip.

8 Updated 510(k) Sterility Review Guidance K90-1; Final Guidance for Industry and FDA

9 21 CFR 820.184 Device History Record

10 See Information Sheet Guidance for Institutional Review Boards (IRBs), Clinical Investigators, and Sponsors

11  See Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features

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.

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