May 27, 1999
Mr. A. Arthur Rankis
140 Locke Drive
Marlborough, MA 01752
|Product:||HemaSure r|LS Pre-Storage Leukoreduction Filtration System for Red Blood Cells|
Dear Mr. Rankis:
We have reviewed your Section 510(K) notification of intent to market the device referenced above and have determined that the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act that include requirements for registration, listing of devices, good manufacturing practice, labeling and prohibitions against misbranding and adulteration.
If your device has been classified into either class II (Special Controls) or class III (Premarket Approval), (see above), it may be subject to the above and additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or regulations.
We recognize your proposal dated May 7, 1999, to actively monitor the first 300 transfusions and to evaluate all reports of Red-Eye reactions.
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a)(I)(A) the device cleared for marketing by this letter as requiring postmarket surveillance.
Within thirty (30) days of receiving this letter prescribing that you are required to conduct postmarket surveillance, you are required to submit to FDA for approval a plan for the required surveillance, including a detailed protocol which describes the study and a detailed profile of the study's principal investigator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.
Submit five (5) copies to:
Center for Biologics Evaluation and Research
Document Control Center, HFM-99
1401 Rockville Pike
Rockville, Maryland 20852
Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been approved. Data generated under an unapproved protocol may not satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting Regulations (21 CFR 803).
Failure to submit timely and acceptable protocol, or to undertake and complete a FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obligations under section 522 is a prohibited act under section 301(q)(I)(C) of the Act (21 U.S.C. 331 (q)(I)(C). Further, under section 502(t)(3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
If you have questions concerning postmarket surveillance study requirements, contact Martin E. Northern at (301) 827-6124.
This letter immediately will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance and Biologic Quality at (301) 827-3754. Additionally, for questions of the promotion and advertising of your device, please contact the Advertising and Promotional Labeling staff at (301) 827-3028. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97) Other general information on your responsibilities under the act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www/fda/gov/cdrh/dsmamain.html".
Jay S. Epstein, M.D.
Office of Blood Research and Review
Center for Biologics Evaluation and Research