Thisguidancewaswrittenpriorto.PDF

This guidance was written prior to the February 27, 1997 implementation of FDAs Good Guidance Practices, GGPs. It does not create or confer rights for or on any person and does not operate to bind FDA or the public. An alternative approach may be used if such approach satisfies the requirements of the applicable statute, regulations, or both. This guidance will be up dated in the next revision to include the standard elemnt s of GGP s . subject: ENIMSCOZ)Y AND UWAROSCOPY ACCESSORXPS The Food and. Drug ~aalnistsation~s(Fa) Center for Dcvices and Radiological Health (CDRK) has recently learned that same mcdioal dwlco ii- comerciall~marke-ting accessoriee to andoscopes/laparoacopes without ~ubrttinga premarket notifiaation for the accessory, as required by -tion 510 (k) at the Faod Drug and Cosmetic Act (Ute Act). Endoscopes/ laparoscopes have been classified by FDA 65 class Z$ pdioal devices - ~itle21, Code of Federal Regulatiom (21 CFR 876-1500), identifie and classifie~en86scope9/laparoscopc8 and accessories as clafis I1 devices. FDA has detedned, in accordance with our ragulations, that wheh an accqssory to a devica is intended to be used with a class lZ device, then that accessory becomas a class I1 device nad is subyeot: Co premarkst notification requfuements. Examples of devices which are consLered accessories to endoscope8/lapa~aecopes include, bu6 are not limited CQ clsanlng accessories, photographic accessories, binocular attachments, pocket battery boxes, fiberoptiu illuminators, lamps, cytology brushec, lubricating jelly for transurethral surgical j.n=trumits, and lagaroscopic sampling acconsories (including probcs, scissors, Eorceps, graspers, and dissectors) . Failure to submit a pramarket notiffcation at leaat nincty (go) days before you prupoae to inkod\t6-0 device. in intoretake commerce is a prohibited act under section 301(p) of the Act, and results in the