![]() You should also refer to 21 CFR 807.87, Guidance for Industry and FDA Staff: Format for Traditional and Abbreviated 510(k)s 1. This document supplements other FDA documents regarding the content requirements of a premarket notification submission. In addition, other sections of this special control guidance document list the risks to health identified by FDA and describe measures that, if followed by manufacturers and combined with the general controls, will generally address the risks associated with the non-powered suction apparatus device intended for NPWT and lead to a timely 510(k) review. This special control guidance document identifies the classification regulation and product code for the non-powered suction apparatus device intended for NPWT (Please refer to Section 3. Thus, a manufacturer who intends to market a device of this generic type must (1) conform to the general controls of the Federal Food, Drug, and Cosmetic Act (the Act), including the premarket notification requirements described in 21 CFR 807 Subpart E, (2) address the specific risks to health associated with non-powered suction apparatus device intended for NPWT identified in this guidance and, (3) obtain a substantial equivalence determination from FDA prior to marketing the device. However, the firm need only show that its device meets the provisions of the guidance or in some other way provides equivalent assurances of safety and effectiveness.įDA believes that special controls, when combined with the general controls, will be sufficient to provide reasonable assurance of the safety and effectiveness of the non-powered suction apparatus device intended for NPWT. This guidance is issued in conjunction with a Federal Register notice announcing the classification of the non-powered suction apparatus device intended for NPWT.įollowing the effective date of the final rule classifying the device, any firm submitting a premarket notification (510(k)) for a non-powered suction apparatus device intended for NPWT will need to address the issues covered in the special control guidance. It is further indicated for management of wounds, burns, ulcers, flaps, and grafts. The device is indicated for wound management via application of negative pressure to the wound for removal of fluids, including wound exudate, irrigation fluids, and infectious materials. ![]() This guidance document was developed as a special control guidance to support the classification of the non-powered suction apparatus device intended for negative pressure wound therapy (NPWT) into class II (special controls). If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. This guidance represents the Food and Drug Administration's (FDA's) current thinking on this topic. ![]() ![]() Table of ContentsĬlass II Special Controls Guidance Document: Non-powered Suction Apparatus Device Intended for Negative Pressure Wound Therapy (NPWT) Please use the document number 1702 to identify the guidance you are requesting. You may also send an e-mail request to to receive a copy of the guidance. Additional CopiesĪdditional copies are available from the Internet. Comments may not be acted upon by the Agency until the document is next revised or updated. Please identify your comments with the docket number listed in the notice of availability that publishes in the Federal Register announcing the availability of this guidance document. Alternatively, electronic comments may be submitted to. Written comments and suggestions may be submitted at any time for Agency consideration to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852. Plastic and Reconstructive Surgery Devices Branchĭivision of Surgical, Orthopedic and Restorative Devices at (301) 796-5650 or by email at Department of Health and Human ServicesĬenter for Devices and Radiological Health For questions regarding this document, contact Jiyoung M.
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