the infusion needle at a rate of 50 milliliters per hour. The test shall be terminated when the tampon is saturated and the first drop of fluid exits the apparatus. (The test result shall be discarded if fluid is detected in the folds of the condom before the tampon is saturated). The water is then drained and the tampon is removed and imme diately weighed to the nearest 0.01 gram. The absorbency of the tampon is determined by subtracting its dry weight from this value. The condom shall be replaced after 10 tests or at the end of the day during which the condom is used in testing, whichever occurs first. (3) The Food and Drug Administration may permit the use of an absorbency test method different from the test method specified in this section if each of the following conditions is met: (i) The manufacturer presents evidence, in the form of a citizen petition submitted in accordance with the requirements of §10.30 of this chapter, demonstrating that the alternative test method will yield results that are equivalent to the results yielded by the test method specified in this section; and (ii) FDA approves the method and has published notice of its approval of the alternative test method in the FEDERAL REGISTER. (g) Any menstrual tampon intended to be dispensed by a vending machine is exempt from the requirements of this section. (h) Any menstrual tampon that is not labeled as required by paragraphs (c), (d), and (e) of this section and that is initially introduced or initially delivered for introduction into commerce after March 1, 1990, is misbranded under sections 201(n), 502 (a) and (f) of the act. (Information collection requirements contained in paragraphs (e) and (f) were approved by the Office of Management and Budget under control number 0910-0257) [47 FR 26989, June 22, 1982, as amended at 54 FR 43771, Oct. 26, 1989; 55 FR 17600, Apr. 26, 1990] Subpart B-Generally Applicable Requirements for Individual Adverse Event Reports 803.20 How to report. Subpart C-User Facility Reporting 803.30 Individual adverse event reports; user facilities. 803.32 Individual adverse event report data elements. 803.33 Semiannual reports. Subpart D-(Reserved) Subpart E-Manufacturer Reporting 803.50 Individual adverse event reports; manufacturers. 803.52 Individual adverse event report data elements. 803.53 Five-day reports. AUTHORITY: Secs. 502, 510, 519, 520, 701, 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 352, 360, 3601, 360), 371, 374). SOURCE: 60 FR 63597, DEC. 11, 1995, UNLESS OTHERWISE NOTED. EFFECTIVE DATE NOTE: At 60 FR 63597, Dec. 11, 1995, part 803 was revised, effective April 11, 1996. For the convenience of the reader the superseded text is set forth following the revised text. Subpart A-General Provisions $803.1 Scope. (a) This part establishes requirements for medical device reporting. Under this part, device user facilities and manufacturers must report deaths and serious injuries to which a device has or may have caused or contributed, and must establish and maintain adverse event files. Manufacturers are also required to report certain device malfunctions and submit an annual report to FDA certifying that the correct number of medical device reports were filed during the previous 12-month period or, alternatively, that no reports were required during that same time period. These reports will assist FDA in protecting the public health by helping to ensure that devices are not adul terated or misbranded and are safe and effective for their intended use. (b) This part supplements and does not supersede other provisions of this subchapter, including the provisions of part 820 of this chapter. (c) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of title 21, unless otherwise noted. 8803.3 Definitions. (a) Act means the Federal Food, Drug, and Cosmetic Act. (b) Ambulatory surgical facility (ASF) means a distinct entity that operates for the primary purpose of furnishing same day outpatient surgical services to patients. An ASF may be either an independent entity (i.e., not a part of a provider of services or any other facility) or operated by another medical entity (e.g., under the common ownership, licensure or control of an entity). An ASF is subject to this regulation regardless of whether it is licensed by a Federal, State, municipal, or local government or regardless of whether it is accredited by a recognized accreditation organization. If an adverse event meets the criteria for reporting, the ASF must report that event regardless of the nature or location of the medical service provided by the ASF. (c) Become aware means that an employee of the entity required to report has acquired information reasonably suggesting a reportable adverse event has occurred. Device user facilities are considered to have "become aware" when medical personnel, as defined in paragraph (r) of this section, who are employed by or otherwise formally affiliated with the facility, acquire such information about a reportable event. Manufacturers are considered to have "become aware" of an event when: (1) Any employee becomes aware of a reportable event that is required to be reported within 30 days, or that is required to be reported within 5 days pursuant to a written request from FDA under 803.53(b); and (2) Any employee, who is a person with management or supervisory responsibilities over persons with regulatory, scientific, or technical responsibilities, or a person whose duties relate to the collection and reporting of adverse events, becomes aware that a reportable MDR event or events, from any information, including any trend analysis, necessitate remedial action to prevent an unreasonable risk of substantial harm to the public health. (d) Caused or contributed means that a death or serious injury was or may have been attributed to a medical device, or that a medical device was or may have been a factor in a death or serious injury, including events occurring as a result of: (1) Failure; (2) Malfunction; (3) Improper or inadequate design; (4) Manufacture; (5) Labeling; or (6) User error. (e)(1) Device family means a group of one or more devices manufactured by or for the same manufacturer and having the same: (i) Basic design and performance characteristics related to device safety and effectiveness, (ii) Intended use and function, and (iii) Device classification and product code. (2) Devices that differ only in minor ways not related to safety or effectiveness can be considered to be in the same device family. Factors such as brand name and common name of the device and whether the devices were introduced into commercial distribution under the same 510(k) or premarket approval application (PMA), may be considered in grouping products into device families. (f) Device user facility means a hospital, ambulatory surgical facility, nursing home, outpatient diagnostic facility, or outpatient treatment facility as defined in paragraphs (1), (b), (s), (t), and (u), respectively, of this section, which is not a "physician's office," as defined in paragraph (w) of this section. School nurse offices and employee health units are not device user facilities. (g)(h) [Reserved] (1) Expected life of a device (required on the manufacturer's baseline report) means the time that a device is expected to remain functional after it is placed into use. Certain implanted devices have specified “end of life” (EOL) dates. Other devices are not labeled as |