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This article was originally published in The Gray Sheet

Executive Summary

FDA'S PREAMENDMENT CLASS III DEVICES 510(K) INSPECTION PROGRAM had completed three inspections as of Aug. 6, according to the Center for Devices and Radiological Health. The device center began requiring facility inspections prior to clearance of pre-1976 Class III device 510(k)s in April, in a new program designed to assure that manufacturers who intend to market Class III "devices through the 510(k) process are in compliance with the medical device GMP [good manufacturing practices] regulation before the devices are marketed," FDA says in an interoffice memo outlining the respective roles of the device center's office of device evaluation (ODE) and office of compliance (OC). The program had originally been slated to begin in mid- August 1992 but was put on hold while FDA assessed whether it would add "significant delays" to the Class III 510(k) review process ("The Gray Sheet" Aug. 31, 1992, p. 4). For the four-month period between April 6 and Aug. 6, FDA received a total of 54 510(k) applications for preamendment Class III devices. Twenty-one of those applications required inspections, of which three had been completed as of Aug. 6. Of the three inspections, one resulted in a "proceed" determination (meaning that no GMP violations were found), one in a "violative" conclusion, and one is still under review. Under the preclearance inspection program, ODE identifies all preamendment Class III devices among entering 510(k) submissions. ODE then forwards to OC the name of the Class III device, and the name, address, telephone number, facsimile number and registration number, if available, of the manufacturer. If the device is to be marketed as sterile, OC must determine the name and address of the firm that is to sterilize the device. OC then contacts the device manufacturer/sterilizer's local FDA district office to determine whether the firm has had a recent GMP inspection (within the last two years) or is currently in an "unacceptable" state of GMP compliance. If OC determines that the firm has not had a recent inspection, the firm's local district office is required to conduct an inspection of the facility within 60 days of OC's request. If OC determines the firm "unacceptable," either because they have received a recent warning letter or the inspection uncovers serious GMP violations, the office is required to send a letter to the applicant with instructions to contact the appropriate district office to determine what must be done to obtain GMP clearance. Overall, 19 of the 54 preamendment Class III device 510(k) applications received between April 6 and Aug. 6 are proceeding, seven have been postponed, two have been withdrawn and 26 are pending. Of the pending applications, over one-half were delayed either because the company had not yet been inspected or the investigational reports necessary for the device center's office of compliance to render a decision had not yet been received from the district offices. Approximately 130 Class III devices are still eligible for regulatory review via the 510(k) process. The Safe Medical Devices Act of 1990, however, mandates that FDA either call for premarket approval applications or downclassify these pre-1976 devices by Dec. 1, 1995. FDA has already issued proposed calls for PMAs for saline-filled breast implants, penile inflatable implants, testicular gel-filled implants and non-roller cardiovascular bypass pumps ("The Gray Sheet" July 12, p. 5). Other preamendment Class III devices include endosseus implants, cranial electrotherapy devices and eye valve implants. 510(k)s for preamendment Class III devices represent only a fraction of the substantial equivalence applications received by the agency; over the last few months, for example, the device center has been taking in approximately 500 510(k) submissions a month. At that rate, the 54 preamendment Class III device 510(k)s received by FDA during the April to August period would account for only about 3% of total 510(k)s submitted. In the interoffice agreement, FDA says that "because of limited resources," the preclearance program is presently limited to Class III preamendment devices. However, FDA continues to project that should the program prove effective, the center will consider expanding it to include other kinds of 510(k) applications.

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