1 These ranges are defined, respectively, as follows: less than or equal to 6 grams; greater than 6 grams up to and including 9 grams; greater than 9 grams up to and including 12 grams; greater than 12 grams up to and including 15 grams; greater than 15 grams up to and including 18 grams; and greater than 18 grams.

(2) The package label shall include an explanation of the ranges of absorbency and a description of how consumers can use a range of absorbency, and its corresponding absorbency term, to make comparisons of absorbency of tampons to allow selection of the tampons with the minimum absorbency needed to control menstrual flow in order to reduce the risk of contracting TSS.

(f) A manufacturer shall measure the absorbency of individual tampons using the test method specified in paragraph (f)(2) of this section and calculate the mean absorbency of a production run, lot, or batch by rounding to the nearest 0.1 gram.

(1) A manufacturer shall design and implement a sampling plan that includes collection of probability samples of adequate size to yield consistent tolerance intervals such that the probability is 90 percent that at least 90 percent of the absorbencies of individual tampons within a brand and type are within the range of absorbency stated on the package label.

(2) In the absorbency test, an unlubricated condom, with tensile strength between 17 Mega Pascals (MPa) and 30 MPa, as measured according to the procedure in the American Society for Testing and Materials (ASTM), D 3492-83, "Standard Specification for Rubber Contraceptives (Condoms)"

1 Copies of the standard are available from the American Society for Testing and

for determining tensile strength, which is incorporated by reference in accordance with 5 U.S.C. 552(a), is attached to the large end of a glass chamber (or a chamber made from hard transparent plastic) with a rubber band (see Figure 1) and pushed through the small end of the chamber using a smooth, finished rod. The condom is pulled through until all slack is removed. The tip of the condom is cut off and the remaining end of the condom is stretched over the end of the tube and secured with a rubber band. A preweighed (to the nearest 0.01 gram) tampon is placed within the condom membrane so that the center of gravity of the tampon is at the center of the chamber. An infusion needle (14 gauge) is inserted through the septum created by the condom tip until it contacts the end of the tampon. The outer chamber is filled with water pumped from a temperature-controlled waterbath to maintain the average temperature at 27±1 °C. The water returns to the waterbath as shown in Figure 2. Syngyna fluid (10 grams sodium chloride, 0.5 gram Certified Reagent Acid Fushsin, 1,000 milliliters distilled water) is then pumped through 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 immediately 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.

Materials, 1916 Race St., Philadelphia, PA 19103, or available for inspection at the Office of the Federal Register, 800 North Capitol Street NW., suite 700, Washington, DC.

(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 A-General Provisions

§ 803.1 Scope.

(a) FDA is requiring a device manufacturer or importer to report to FDA whenever the manufacturer or importer receives or otherwise becomes aware of information that reasonably suggests that one of its marketed devices (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. These reports will enable FDA to protect the public health by helping to ensure that devices are not adulterated or misbranded and are otherwise safe and effective for their intended use. In addition, a device importer is required to establish and maintain a complaint file and to permit any authorized FDA employee at all reasonable times to have access to and to copy and verify the records contained in this file.

(b) This part supplements, and does not supersede, other provisions of this subchapter, including the provisions of Part 820, such as the requirements under § 820.162 that a manufacturer investigate the failure of a device or any of its components to meet its performance specifications and to establish and maintain a written record of the investigation, including the manufacturer's conclusions and followup, the requirements under § 820.198 that a manufacturer establish and maintain a complaint file, and the requirements under § 820.180 that a manufacturer allow access to, and copying of, these files by any authorized FDA representative.

(c) References in this part to regulatory sections of the Code of Federal Regulations are to Chapter I of Title 21, unless otherwise noted.

§ 803.3 Definitions.

(a) FDA means the Food and Drug Administration.

(b) Importer means any person who imports a device into the United States and is required to register under Part 807.

(c) Malfunction means the failure of a device to meet any of its performance specifications or otherwise to perform as intended. Performance specifications include all claims made in the labeling for the device. The intended performance of a device refers to the objective intent of the person legally responsible for the labeling of the device. The intent is determined by such persons' expressions or may be shown by the circumstances surrounding the distribution of the device. This objective intent may, for example, be shown by labeling claims, advertising matter, or oral or written statements by such persons or their representatives. It also may be shown by the circumstances that the device is, with the knowledge of such persons or their representatives, offered and used to perform a function for which it is neither labeled nor advertised.

(d) Manufacturer means any person who is required to register under Part 807, other than a person who initially distributes a device imported into the United States.

(e) Person includes any individual, partnership, corporation, association, scientific or academic establishment, Government agency, or organizational unit thereof, or any other legal entity.

(f) Information that reasonably suggests a conclusion means: (1) Information (such as professional, scientific, or medical facts or opinions) from which a reasonable person would reach the conclusion, and (2) a statement to a manufacturer or importer by a health care professional (e.g., a doctor of medicine, osteopathy, dental surgery, podiatry, or chiropractic, or an optometrist, pharmacist, or a registered nurse, or a hospital administrator), reaching the conclusion.

(g) A remedial action is any recall, repair, modification, adjustment, relabeling, destruction, inspection (including patient monitoring), notification, or any other action that is initiated by a manufacturer or importer in response to information that it receives or otherwise becomes aware of and that reasonably suggests that one of its marketed devices (1) may have caused or contributed to a death or serious injury or (2) has malfunctioned and that the device or any other

device marketed by the manufacturer or importer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

(h) A serious injury is an injury that (1) is life threatening, (2) results in permanent impairment of a body function or permanent damage to body structure, or (3) necessitates medical or surgical intervention by a health care professional to (i) preclude permanent impairment of a body function or permanent damage to body structure or (ii) relieve unanticipated temporary impairment of a body function or unanticipated temporary damage to body structure. Temporary impairment of a body function or temporary damage to body structure is unanticipated if reference to such impairment or damage is not made in the labeling for the device or, if such reference is made in the labeling for the device, the manufacturer or importer of the device determines that such impairment or damage has occurred or is occurring more frequently or with greater severity than is stated in the labeling for the device or, if there is not any pertinent statement in the labeling, than is usual for the device.

(i) Any term defined in section 201 of the Federal Food, Drug, and Cosmetic Act shall have that meaning, unless otherwise defined in this part.

§ 803.9 Public availability of reports.

(a) Any report, including any FDA record of a telephone report, submitted under this part is available for public disclosure in accordance with Part 20.

(b) Before public disclosure of a report, FDA will delete from the report (1) any information that constitutes trade secret or confidential commercial or financial information under § 20.61; and (2) any personnel, medical, and similar information disclosure of which would constitute a clearly unwarranted invasion of personal privacy under § 20.63; Provided, However, that except for the information that constitutes trade secret or confidential commercial or financial information under § 20.61, FDA will disclose to a patient who requests a report all the informa