must make the reports required under §314.81 and section 505(k) of the Federal Food, Drug, and Cosmetic Act for each of its approved abbreviated applications. [79 FR 33089, June 10, 2014]

, which have met the applicable requirements of §600.11 of this chapter, or from human donor whose blood is positive for hepatitis B surface antigen. [40 FR 29711, July 15, 1975]

package cosmetic products at that location. (b) Physicians, hospitals, clinics, and public health agencies. (c) Persons who manufacture, prepare, compound, or process cosmetic products solely for use in research, pilot plant production, teaching, or chemical analysis, and who do not sell these products.

(a) Identification. A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for cytological examination. (b) Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part

(a) Identification. A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets. (b) Classification. Class II (special controls). The device is

a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient. (b) Classification. Class II (performance standards). [45 FR 60621, Sept. 12, 1980]

(a) Identification. An arterial blood sampling kit is a device, in kit form, used to obtain arterial blood samples from a patient for blood gas determinations. The kit may include a syringe, needle, cork, and heparin. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of

(a) Identification. A gas volume calibrator is a device that is intended for medical purposes and that is used to calibrate the output of gas volume measurement instruments by delivering a known gas volume. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter

(a) Identification. A gas pressure gauge (e.g., bourdon tube pressure gauge) is a device intended for medical purposes that is used to measure gas pressure in a medical gas delivery system. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the

(a) Identification. A carbon dioxide absorbent is a device intended for medical purposes that consists of an absorbent material (e.g., soda lime) that is intended to remove carbon dioxide from the gases in the breathing circuit. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part

(a) Identification. A portable air compressor is a device intended to provide compressed air for medical purposes, e.g., to drive ventilators and other respiratory devices. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in

(a) Identification. A medical gas yoke assembly is a device intended to connect medical gas cylinders to regulators or needle valves to supply gases for anesthesia or respiratory therapy. The device may include a particulate filter. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of

(a) Identification. A paper chart recorder is a device used to print on paper, and create a permanent record of the signal from, for example, a physiological amplifier, signal conditioner, or computer. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter

FDA's guidance document entitled “Class II Special Controls Guidance Document: Implantable Intra-Aneurysm Pressure Measurement System.” See §870.1 (e) for the availability of this guidance document. [71 FR 7871, Feb. 15, 2006]

(a) Identification. A pacemaker polymeric mesh bag is an implanted device used to hold a pacemaker pulse generator. The bag is designed to create a stable implant environment for the pulse generator. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject

(a) Identification. A cardiopulmonary bypass intracardiac suction control is a device which provides the vacuum and control for a cardiotomy return sucker. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in

(a) Identification. A nasopharyngeal catheter is a device consisting of a bougie or filiform catheter that is intended for use in probing or dilating the eustachian tube. This generic type of device includes eustachian catheters. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of

(a) Identification. An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms. (b) Classification. Class II (special controls). The device is

(a) Identification. A skin marker is a pen-like device intended to be used to write on the patient's skin, e.g., to outline surgical incision sites or mark anatomical sites for accurate blood pressure measurement. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this

(a) Identification. A cranial drill handpiece (brace) is a hand holder, which is used without a power source, for drills, burrs, trephines, or other cutting tools that are used on a patient's skull. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject

(a) Identification. An ophthalmic trial lens set is a device that is a set of lenses of various dioptric powers intended to be handheld or inserted in a trial frame for vision testing to determine refraction. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this

(a) Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed. (b) Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from

(a) Identification. A closed-circuit television reading system is a device that consists of a lens, video camera, and video monitor that is intended for use by a patient who has subnormal vision to magnify reading material. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807

(a) Identification. A powered reflex hammer is a motorized device intended for medical purposes to elicit and determine controlled deep tendon reflexes. (b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in

(a) Identification. A miniature pressure transducer is a device intended for medical purposes to measure the pressure between a device and soft tissue by converting mechanical inputs to analog electrical signals. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this

(a) Identification. An air-fluidized bed is a device employing the circulation of filtered air through ceramic spherules (small, round ceramic objects) that is intended for medical purposes to treat or prevent bedsores, to treat severe or extensive burns, or to aid circulation. (b) Classification. Class II (special controls). The device is exempt from the

(a) Identification. A manual patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, or to aid circulation. (b) Classification. Class I (general controls). The device is exempt from the premarket notification

(a) Identification. A powered patient rotation bed is a device that turns a patient who is restricted to a reclining position. It is intended for medical purposes to treat or prevent bedsores, to treat severe and extensive burns, urinary tract blockage, and to aid circulation. (b) Classification. Class II (special controls). The device is exempt from the

(a) Identification. A powered finger exerciser is a device intended for medical purposes to increase flexion and the extension range of motion of the joints of the second to the fifth fingers of the hand. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter

(a) Identification. A powered heating unit is a device intended for medical purposes that consists of an encased cabinet containing hot water and that is intended to heat and maintain hot packs at an elevated temperature. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of