completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before November 21, 2011, for any ventricular bypass (assist) device that was in commercial distribution before May 28, 1976, or that has, on or before November 21, 2011, been found to be substantially equivalent to any ventricular bypass (assist) device that was in commercial distribution before May 28, 1976. Any other ventricular bypass (assist) device shall

completion of PDP is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before September 21, 2004, for any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976, or that has, on or before September 21, 2004, been found to be substantially equivalent to any cardiopulmonary bypass pulsatile flow generator that was in commercial distribution before May 28, 1976. Any other cardiopulmonary

(a) Identification. A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during application of tooth shade material. (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 limitations in

notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 30, 1999, for any total temporomandibular joint prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before March 30, 1999, been found to be substantially equivalent to a total temporomandibular joint prosthesis that was in commercial distribution before May 28, 1976. Any other total

notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 30, 1999, for any mandibular condyle prosthesis that was in commercial distribution before May 28, 1976, or that has, on or before March 30, 1999, been found to be substantially equivalent to a mandibular condyle prosthesis that was in commercial distribution before May 28, 1976. Any other mandibular condyle prosthesis shall have an approved PMA or a declared completed PDP in effect before

required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 30, 1999, for any interarticular disc prosthesis (interpositional implant) that was in commercial distribution before May 28, 1976, or that has on or before March 30, 1999, been found to be substantially equivalent to an interarticular disc prosthesis (interpositional implant) that was in commercial distribution before May 28, 1976. Any other interarticular disc

product development protocol (PDP) is required. A PMA or notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before July 5, 1995, for any testicular prosthesis that was in commercial distribution before May 28, 1976, or that has on or before July 5, 1995, been found to be substantially equivalent to a testicular prosthesis that was in commercial distribution before May 28, 1976. Any other testicular prosthesis shall have an approved PMA or a

cannula and trocar. (b) Classification. (1) Class II (performance standards). (2) Class I for the catheter punch instrument, nondisposable cannula and trocar, and gastro-urological trocar. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in

(a) Identification. A therapeutic scrotal support is a device intended for medical purposes that consist of a pouch attached to an elastic waistband and that is used to support the scrotum (the sac that contains the testicles). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part

(a) Identification. A hot/cold water bottle is a device intended for medical purposes that is in the form of a container intended to be filled with hot or cold water to apply heat or cold to an area of the body. (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 cast cover is a device intended for medical purposes that is made of waterproof material and placed over a cast to protect it from getting wet during a shower or a bath. (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 ring cutter is a device intended for medical purposes that is used to cut a ring on a patient's finger so that the ring can be removed. The device incorporates a guard to prevent injury to the patient's finger. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of

(a) Identification. An examination gown is a device intended for medical purposes that is made of cloth, paper, or other material that is draped over or worn by a patient as a body covering during a medical examination. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of

(special controls). The special controls for this device are: (1) The device must be demonstrated to be biocompatible and non-toxic; (2) Nonclinical, animal, and clinical testing must provide a reasonable assurance of safety and effectiveness, including device performance, durability, compatibility, usability (human factors testing), event recording, and proper excretion of the device; (3) Appropriate

(a) Identification. A skin pressure protector is a device intended for medical purposes that is used to reduce pressure on the skin over a bony prominence to reduce the likelihood of the patient's developing decubitus ulcers (bedsores). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E

(a) Identification. A tuning fork is a mechanical device which resonates at a given frequency and is used to diagnose hearing disorders and to test for vibratory sense. (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 limitations in

(a) Identification. A diagnostic Hruby fundus lens is a device that is a 55 diopter lens intended for use in the examination of the vitreous body and the fundus of the eye under slitlamp illumination and magnification. (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 fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (§886.1870). (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E

(a) Identification. A low-power binocular loupe is a device that consists of two eyepieces, each with a lens or lens system, intended for medical purposes to magnify the appearance of objects. (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

(a) Identification. A low-vision magnifier is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device may be held in the hand or attached to spectacles. (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. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print. (b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of

(a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading. (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 limitations in

(a) Identification. An image intensification vision aid is a battery-powered device intended for use by a patient who has limited dark adaptation or impaired vision to amplify ambient light. (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 cast component is a device intended for medical purposes to protect or support a cast. This generic type of device includes the cast heel, toe cap, cast support, and walking iron. (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 cane is a device intended for medical purposes that is used to provide minimal weight support while walking. Examples of canes include the following: A standard cane, a forearm cane, and a cane with a tripod, quad, or retractable stud on the ground end. (b) Classification. Class I (general controls). The device is exempt from the

(a) Identification. A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints. (b)

(a) Identification. A nonpowered communication system is a mechanical device intended for medical purposes that is used to assist a patient in communicating when physical impairment prevents writing, telephone use, reading, or talking. Examples of nonpowered communications systems include an alphabet board and a page turner. (b) Classification. Class I

(a) Identification. A wheelchair platform scale is a device with a base designed to accommodate a wheelchair. It is intended for medical purposes to weigh a person who is confined to a wheelchair. (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

(a) Identification. A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function. (b) Classification. Class I (general controls). The device is exempt from the premarket

(a) Identification. A traction accessory is a nonpowered accessory device intended for medical purposes to be used with powered traction equipment to aid in exerting therapeutic pulling forces on the patient's body. This generic type of device includes the pulley, strap, head halter, and pelvic belt. (b) Classification. Class I (general controls). The device