The Food and Drug Administration is asking for comments on a draft guidance entitled “Refuse to Accept Policy for 510(k)s,” which explains the procedures and criteria FDA intends to use in determining whether a premarket notification (510(k)) submission is administratively complete and should be accepted for substantive review. FDA’s draft guidance is not in effect, but once it’s final it will be applicable to 510(k)s reviewed in the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER). Comments should be submitted by Sept. 27 to ensure consideration before the final version of this guidance is published.

On Aug. 8 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

The Food and Drug Administration issued its weekly Enforcement Report for Aug. 8 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.

The Food and Drug Administration is seeking nominations for a nonvoting industry representative(s) on the Pediatric Advisory Committee to the Office of the Commissioner. Nominations are due by Sept. 10. Organizations interested in assisting FDA in selecting the committee members should also notify FDA by Sept. 10.

On Aug. 7 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

Chinese drug manufacturer Jiangsu Province Jianerkang Medical Dressing will remain on import alert, and approval of new applications or supplements withheld, until it implements a robust quality system to comply with current good manufacturing practices (CGMP), said the Food and Drug Administration in a warning letter sent July 30. A Sept. 2011 inspection had found numerous violations of CGMP including, among other things, bacteria on antiseptic wipes manufactured by Jainerkang intended for use on wounds. The firm’s Oct. 2011 response to the inspection lacked sufficient corrective actions, FDA said.

On Aug. 6 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:

During the week of July 30 - Aug. 5, the Food and Drug Administration modified the following existing Import Alerts (not otherwise listed on the FDA's new and revised import alerts page) on the detention without physical examination of:

The Food and Drug Administration, in cosponsorship with Parenteral Drug Association (PDA), announced a public conference Sept.10-12 in Baltimore on "Compliance Through Quality Systems: Implementing and Advancing a Sustainable Global Quality Culture." The conference will cover issues affecting the industry and explore strategies and approaches for ensuring conformance with regulations to facilitate the development and continuous improvement of safe and effective medical products, FDA said.

On Aug. 3 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of: