www.gpo.gov/fdsys/pkg/CFR-2011-title21-vol8/pdf/CFR-2011-title21-vol8-sec888-5.pdf.

PDF File: Food and Drug Administration, HHS CFR-2011-title21-vol8-sec888-5

Food and Drug Administration, HHS

513(f) of the act) into class III without any grace period and FDA must have issued an order approving a PMA or de­claring completed a PDP for the device before the device is commercially dis­tributed unless it is reclassified. If FDA knows that a device being com­mercially distributed may be a ‘‘new’’ device as defined in this section be­cause of any new intended use or other reasons, FDA may codify the statutory classification of the device into class III for such new use. Accordingly, the regulation for such a class III device states that as of the enactment date of the amendments, May 28, 1976, the de­vice must have an approval under sec­tion 515 of the act before commercial distribution.

(c) A device identified in a regulation in this part that is classified into class III and that is subject to the transi­tional provisions of section 520(1) of the act is automatically classified by stat­ute into class III and must have an ap­proval under section 515 of the act be­fore being commercially distributed. Accordingly, the regulation for such a class III transitional device states that as of the enactment date of the amend­ments, May 28, 1976, the device must have an approval under section 515 of the act before commercial distribution.

§ 888.5 Resurfacing technique.

Because of resurfacing techniques, certain joint prostheses require far less bone resection than other devices in­tended to repair or replace the same joint. The amount of bone resection may or may not affect the safety and effectiveness of the implantation of the prosthesis. When a resurfacing tech­nique is used, the name of the pros­thesis includes this information.

§ 888.6 Degree of constraint.

Certain joint prostheses provide more constraint of joint movement than oth­ers. FDA believes that the degree of constraint is an important factor af­fecting the safety and effectiveness of orthopedic prostheses. FDA is defining the following standard terms for cat­egorizing the degree of constraint.

(a)   A “constrained” joint prosthesis is used for joint replacement and pre­vents dislocation of the prosthesis in more than one anatomic plane and con-sists of either a single, flexible, across- the-joint component or more than one componentlinked together or affined.

(b)    A ‘‘semi-constrained’’ joint pros­thesis is used for partial or total joint replacement and limits translation and rotation of the prosthesis in one or more planes via the geometry of its ar­ticulating surfaces. It has no across- the-joint linkage.

(c)    A ‘‘non-constrained’’ joint pros­thesis is used for partial or total joint replacement and restricts minimally prosthesis movement in one or more planes. Its components have no across- the-joint linkage.

§ 888.9 Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).

The exemption from the requirement of premarket notification (section 510(k) of the act) for a generic type of class I or II device is only to the extent that the device has existing or reason­ably foreseeable characteristics of commercially distributed devices with­in that generic type or, in the case of in vitro diagnostic devices, only to the extent that misdiagnosis as a result of using the device would not be associ­ated with high morbidity or mortality. Accordingly, manufacturers of any commercially distributed class I or II device for which FDA has granted an exemption from the requirement of premarket notification must still sub­mit a premarket notification to FDA before introducing or delivering for in­troduction into interstate commerce for commercial distribution the device when:

(a)    The device is intended for a use different from the intended use of a le­gally marketed device in that generic type of device; e.g., the device is in­tended for a different medical purpose, or the device is intended for lay use where the former intended use was by health care professionals only;

(b)    The modified device operates using a different fundamental sci­entific technology than a legally mar­keted device in that generic type of de­vice; e.g., a surgical instrument cuts tissue with a laser beam rather than with a sharpened metal blade, or an in vitro diagnostic device detects or iden­tifies infectious agents by using

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