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Page 398 418 435 456 479 505 522 535







General hospital and personal use devices ...
Neurological devices .......
Obstetrical and gynecological devices
Ophthalmic devices .......
Orthopedic devices .........
Physical medicine devices .......
Radiology devices
Banned devices ........
Performance standard for electrode lead wires and

patient cables ..

General .......
Records and reports .........
Notification of defects or failure to comply
Repurchase, repairs, or replacement of electronic
products ............

Importation of electronic products ....
Performance standards for electronic products:

General ......
Performance standards for ionizing radiation emit-

ting products ........
Performance standards for microwave and radio

frequency emitting products ............
Performance standards for light-emitting products
Performance standards for sonic, infrasonic, and

ultrasonic radiation-emitting products

1000 1002 1003 1004

578 587 595

599 601

1005 1010






1040 1050

660 683







1210 Regulations under the Federal Import Milk Act ....
1230 Regulations under the Federal Caustic Poison Act
1240 Control of communicable diseases .....
1250 Interstate conveyance sanitation ......
1270 Human tissue intended for transplantation .........

Human cells, tissues, and cellular and tissue-based

products ...... 1272_1299[Reserved]





Subpart A [Reserved)
Subpart B--Requirements for Specific

Medical Devices 800.10 Contact lens solutions; sterility. 800.12 Contact lens solutions and tablets;

tamper-resistant packaging. 800.20 Patient examination gloves and sur

geons' gloves; sample plans and test

method for leakage defects; adulteration. Subpart C-Administrative Practices and

Procedures 800.55 Administrative detention.

AUTHORITY: 21 U.S.C. 321, 334, 351, 352, 355, 360e, 3600, 360k, 361, 362, 371.

Subpart A [Reserved]

tions. By the regulation in $200.50 of this chapter, this ruling is applicable to ophthalmic preparations that are regulated as drugs.

(3) The containers shall be sterile at the time of filling and closing, and the container or individual carton shall be so sealed that the contents cannot be used without destroying the seal. The packaging and labeling of these solutions shall also comply with 8 800.12 on tamper-resistant packaging requirements.

(b) Liquid ophthalmic preparations packed in multiple-dose containers should:

(1) Contain one or more suitable and harmless substances that will inhibit the growth of microorganisms; or

(2) Be so packaged as to volume and type of container and so labeled as to duration of use and with such necessary warnings as to afford adequate protection and minimize the hazard of injury resulting from contamination during use.

(c) Eye cups, eye droppers, and other dispensers intended for ophthalmic use should be sterile, and may be regarded as falling below their professed standard of purity or quality if they are not sterile. These articles, which are regulated as medical devices unless packaged with the drugs with which they are to be used, should be packaged so as to maintain sterility until the package is opened and be labeled, on or within the retail package, so as to afford adequate directions and necessary warnings to minimize the hazard of injury resulting from contamination during use. [47 FR 50455, Nov. 5, 1982)

Subpart Requirements for

Specific Medical Devices $ 800.10 Contact lens solutions; ste

rility. (a)(1) Informed medical opinion is in agreement that all preparations offered or intended for ophthalmic use, including contact lens solutions, should be sterile. It is further evident that such preparations purport to be of such purity and quality as to be suitable for safe use in the eye.

(2) The Food and Drug Administration concludes that all such preparations, if they are not sterile, fall below their professed standard of purity or quality and may be unsafe. In a statement of policy issued on September 1, 1964, the Food and Drug Administration ruled that liquid preparations offered or intended for ophthalmic use that are not sterile may be regarded as adulterated within the meaning of section 501(c) of the Federal Food, Drug, and Cosmetic Act (the act), and, further, may be deemed misbranded with in the meaning of section 502(j) of the act. By this regulation, this ruling is applicable to all preparations for ophthalmic use that are regulated as medical devices, i.e., contact lens solu

$800.12 Contact lens solutions and

tablets; tamper-resistant packaging. (a) General. Unless contact lens solutions used, for example, to clean, disinfect, wet, lubricate, rinse, soak, or store contact lenses and salt tablets or other dosage forms to be used to make any such solutions are packaged in tamper-resistant retail packages, there is the opportunity for the malicious adulteration of these products with

risks both to individuals who unknow- a visual indication of package integingly purchase adulterated products rity. The tamper-resistant feature and with loss of consumer confidence shall be designed to and shall remain in the security of the packages of over intact when handled in a reasonable the-counter (OTC) health care prod- manner during manufacture, distribuucts. The Food and Drug Administra- tion, and retail display. tion has the authority and responsi- (c) Labeling. Each retail package of a bility under the Federal Food, Drug, product covered by this section is reand Cosmetic Act (the act) to establish quired to bear a statement that is a uniform national standard for tam prominently placed so that consumers per-resistant packaging of those OTC are alerted to the tamper-resistant feaproducts vulnerable to malicious adul ture of the package. The labeling stateteration that will improve the security ment is also required to be so placed of OTC packaging and help assure the that it will be unaffected if the tampersafety and effectiveness of the products resistant feature of the package is contained therein. A contact lens solu breached or missing. If the tamper-retion or tablet or other dosage form to sistant feature chosen to meet the rebe used to make such a solution for re quirement in paragraph (b) of this sectail sale that is not packaged in a tam tion is one that uses an identifying per-resistant package and labeled in characteristic, that characteristic is accordance with this section is adulter- required to be referred to in the labelated under section 501 of the act or ing statement. For example, the labelmisbranded under section 502 of the ing statement on a bottle with a shrink act, or both.

band could say “For your protection, (b) Requirement for tamper-resistant this bottle has an imprinted seal package. Each manufacturer and pack- around the neck." er who packages for retail sale a prod. (d) Requests for exemptions from packuct regulated as a medical device that aging and labeling requirements. A manis a solution intended for use with con- ufacturer or packer may request an extact lenses, e.g., for cleaning, dis emption from the packaging and labelinfecting, wetting, lubricating, rinsing, ing requirements of this section. A resoaking, or storing contact lenses or quest for an exemption is required to tablets or other dosage forms to be be submitted in the form of a citizen used to make any such solution shall petition under $10.30 of this chapter package the product in a tamper-resist- and should be clearly identified on the ant package, if this product is acces- envelope as a “Request for Exemption sible to the public while held for sale. from Tamper-resistant Rule.” A petiA tamper-resistant package is one hav tion for an exemption from a requireing an indicator or barrier to entryment of this section is required to conwhich, if breached or missing, can rea tain the same kind of information sonably be expected to provide visible about the product as is specified for evidence to consumers that tampering OTC drugs in $211.132(d) of this chaphas occurred. To reduce the likelihood ter. This information collection reof substitution of a tamper-resistant quirement has been approved by the Offeature after tampering, the indicator fice of Management and Budget under or barrier to entry is required to be dis- number 0910_0150. tinctive by design or by the use of an (e) Products subject to approved preidentifying characteristic (e.g., a pat market approval applications. Holders of tern, name, registered trademark, logo, approved premarket approval applicaor picture). For purposes of this sec tions for products subject to this section, the term “distinctive by design" tion are required to submit supplemeans the package cannot be dupli- ments to provide for changes in packcated with commonly available mate aging to comply with the requirement rial or through commonly available of paragraph (b) of this section unless processes. A tamper-resistant package these changes do not affect the commay involve an immediate-container position of the container, the torque and closure system or secondary-con- (tightness) of the container, or the tainer or carton system or any com- composition of the closure component bination of systems intended to provide in contact with the contents (cap liner or innerseal) as these features are de- after May 5, 1983, are required to be in scribed in the approved premarket ap compliance with all aspects of the regproval application. Any supplemental ulations without regard to the retail premarket approval application under level effective date. this paragraph is required to include data sufficient to show that these

[47 FR 50455, Nov. 5, 1982; 48 FR 1706, Jan. 14,

1983, as amended at 48 FR 16666, Apr. 19, 1983; changes do not adversely affect the

48 FR 37625, Aug. 19, 1983; 53 FR 11252, Apr. 6, product.

1988] (f) Effective date. Each product subject to this section is required to com

EFFECTIVE DATE NOTE: A document pubply with the requirements of this sec

lished at 48 FR 41579, Sept. 16, 1983, stayed tion on the dates listed below except to

the effective date of $800.12(f)(3) until further

notice. the extent that a product's manufacturer or packer has obtained an exemp

8 800.20 Patient examination gloves tion from a packaging or labeling re

and surgeons' gloves; sample plans quirement:

and test method for leakage defects; (1) Initial effective date for packaging adulteration. requirements. (i) The packaging require

(a) Purpose. The prevalence of human ment in paragraph (b) of this section is

immunodeficiency virus (HIV), which effective on February 7, 1983 for each

causes acquired immune deficiency contact lens solution packaged for retail sale on or after that date, except

syndrome (AIDS), and its risk of trans

mission in the health care context, for the requirement in paragraph (b) of

have caused the Food and Drug Adminthis section for a distinctive indicator

istration (FDA) to look more closely at or barrier to entry. (ii) The packaging requirement in

the quality control of barrier devices,

such as surgeons' gloves and patient paragraph (b) of this section is effective on May 5, 1983 for each tablet that

examination gloves (collectively is to be used to make a contact lens so

known as medical gloves) to reduce the lution and that is packaged for retail

risk of transmission of HIV and other sale on or after that date.

blood-borne infectious diseases. The (2) Initial effective date for labeling re

Centers for Disease Control (CDC) recquirements. The requirement in para

ommend that health care workers wear graph (b) of this section that the indi

medical gloves to reduce the risk of cator or barrier to entry be distinctive

transmission of HIV and other bloodby design and the requirement in para

borne infectious deseases. The CDC recgraph (c) of this section for a labeling

ommends that health care workers statement are effective on May 5, 1983

wear medical gloves when touching for each product subject to this section

blood or other body fluids, mucous packaged for retail sale on or after

membranes, or nonintact skin of all pathat date, except that the requirement

tients; when handling items or surfaces for a specific label reference to any

soiled with blood or other body fluids; identifying characteristic is effective

and when performing venipuncture and on February 6, 1984 for each affected other vascular access procedures. product subject to this section pack Among other things, CDC's recaged for retail sale on or after that ommendation that health care prodate.

viders wear medical gloves dem(3) Retail level effective date. The tam onstrates the proposition that devices per-resistant packaging requirement of labeled as medical gloves purport to be paragraph (b) of this section is effec

and are represented to be effective bartive on February 6, 1984 for each prod riers against the transmission of blooduct subject to this section that is held and fluid-borne pathogens. Therefore, for sale at retail level on or after that FDA, through this regulation, is defindate that was packaged for retail sale ing adulteration for patient examinabefore May 5, 1983. This does not in- tion and surgeons' gloves as a means of clude the requirement in paragraph (b) assuring safe and effective devices. of this section that the indicator or (1) For a description of a patient exbarrier to entry be distinctive by de- amination glove, see $880.6250. Finger sign. Products packaged for retail sale cots, however, are excluded from the test method and sample plans in para ed for the sample. Attach the glove to graphs (b) and (c) of this section.

the plastic fill tube by bringing the (2) For a description of a surgeons cuff end to the 142-inch mark and fasglove, see $ 878.4460 of this chapter,

tening with elastic strapping to make a (b) Test method. For the purposes of watertight seal. Add 1,000 mL of room this regulation, FDA's analysis of temperature water (i.e., 20 °C to 30 °C) gloves for leaks will be conducted by a into the open end of the fill tube. The water leak method, using 1,000 milli water shall pass freely into the glove. liters (mL) of water. Each medical (With some larger sizes of long-cuffed glove will be analyzed independently.

surgeons' gloves, the water level may When packaged as pairs, each glove is

reach only the base of the thumb. With considered separately, and both gloves

some smaller gloves, the water level will be analyzed. A defect on one of the

may extend several inches up the fill gloves is counted as one defect; a de

tube.) fect in both gloves is counted as two

(3) Immediately after adding the defects. Defects are defined as leaks,

water, examine the glove for water tears, mold, embedded foreigh objects,

leaks. Do not squeeze the glove; use etc. A leak is defined as the appearance

only minimal manipulation to spread of water on the outside of the glove.

the fingers to check for leaks. Water This emergence of water from the glove

drops may be blotted to confirm leakconstitutes a watertight barrier fail

ing. If the glove does not leak immeure. Leaks within 1 and 12 inches of the cuff are to be disregarded.

diately, keep the glove/filling tube as(1) The following materials are re

sembly upright and hang the assembly quired for testing: A 23/8-inch by 15-inch

vertically from the horizontal rod, (clear) plastic cylinder with a hook on

using the wire hook on the open end of one end and a mark scored 14/2 inches

the fill tube (do not support the filled from the other end (a cylinder of an

glove while transferring). Make a secother size may be used if it accommo

ond observation for leaks 2 minutes dates both cuff diameter and any water

after addition of the water to the above the glove capacity); elastic

glove. Use only minimal manipulation strapping with velcro or other fas

of the fingers to check for leaks. tening material: automatic water-dis- Record the number of defective gloves. pensing apparatus or manual device ca (c) Sample plans. FDA will collect pable of delivering 1,000 mL of water; a samples from lots of gloves to perform stand with horizontal rod for hanging the test for defects described in parathe hook end of the plastic tube. The graph (b) of this section in accordance support rod must be capable of holding with FDA's sampling inspection plans the weight of the total number of which are based on the tables of MILgloves that will be suspended at any STD-105E (the military sampling one time, e.g., five gloves suspended standard, “Sampling Procedures and will weigh about 11 pounds.

Tables for Inspection by Attributes," (2) The following methodology is May 10, 1989). Based on the acceptable used: Examine the sample and identify quality levels found in this standard, code/ lot number, size, and brand as ap- FDA has defined adulteration as folpropriate. Examine gloves for defects lows: 2.5 or higher for surgeons' gloves as follows: carefully remove the glove and 4.0 or higher for patient examinafrom the wrapper, box, etc., visually tion gloves at a general inspection examining each glove for defects. Vis level II. FDA will use single normal ual defects in the top 142 inches of a sampling for lots of 1,200 gloves or less glove will not be counted as a defect and multiple normal sampling for all for the purposes of this rule. Visually larger lots. For convenience, the samdefective gloves do not require further ple plans (sample size and accept/reject testing but are to be included in the numbers) are shown in the following total number of defective gloves count- tables:

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