On May 6 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 will hold a workshop June 5 in Silver Spring, Md. to discuss the guidance development process for medical devices. At the meeting, FDA will discuss with the public best practices in guidance development, as well as how the agency’s Center for Devices and Radiological Health should develop its guidance priorities. Registration is required by May 29 to attend the meeting in person or watch the meeting via webcast.
During the week of April 28 - May 4, 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 and/or surveillance of:
On May 5 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
The number of warning letters issued by the Food and Drug Administration for violations of quality system regulations by medical devices steadily rose between 2009 and 2012, according to data recently released by the agency. That’s partly a result of more inspections, but is also the result of an increased focus on foreign firms, said FDA in the FDA Medical Device 2012 Quality System Data posted to FDA’s website May 2.
The proportion of additions to the Food and Drug Administration’s Reportable Food Registry involving imports has fallen each year since the program began in 2009, according to the 4th Reportable Food Registry Annual Report issued May 5. The report on FDA’s listing of human and animal foods that are food safety risks shows first-time entries both imported and domestic at their lowest level since reporting began, although the total number of reports is at its highest level since 2009-10. Undeclared allergens remains the top reason for filing reports, while salmonella in spices was the most common hazard for imports in 2012-13.
Amid explosive growth in imports of drugs and devices from China, the Food and Drug Administration is stepping up its efforts in the country to improve safety, said Christopher Hickey, FDA China director, in a recent blog post. From 2007 to 2013, the total number of FDA-regulated shipments from China to the U.S. nearly quadrupled, said Hickey on April 17. In response, FDA is increasing its staff in China and is improving its collaborative efforts with Chinese regulators, he said.
The Food and Drug Administration posted a draft guidance for industry and FDA staff on the agency’s regulation of surveying, leveling, or alignment (SLA) Laser Products. The question and answer document outlines FDA’s proposed approach on the applicability of FDA performance standard regulations to these laser products. It includes design features of surveying, leveling or alignment lasers and a discussion of class limits, and says a laser product manufacturer may not avoid designation of its product as an SLA laser simply by marketing it as a laser for other uses. A concurrently issued Federal Register notice (here) says comments on the draft guidance are due Aug. 4.
On May 2 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 on May 2 released a Food Safety Modernization Act (FSMA) Operational Strategy document intended to guide the agency’s efforts as it looks to bring industry into compliance with new regulations and oversee its new programs. “The agency has to design methods to promote widespread voluntary industry compliance with the new rules, as well as establish preventive public health-focused inspection and sampling programs to oversee compliance,” it said in an emailed announcement. “In addition, the FDA is developing effective enforcement strategies to be deployed when producers, processors, distributors and importers fail to comply on a voluntary basis.”