The Food and Drug Administration is proposing to amend its radiological health regulations to “reduce regulatory requirements that are outdated and duplicate other means to better protect the public health against harmful exposure to radiation emitting electronic products and medical devices,” it said in a notice. Among other things, FDA’s proposed rule would amend record-keeping and reporting requirements for electronics and medical devices by reducing some annual report and test record requirements, and cut back on some regulatory requirements for uncertified products incorporated into an electronic product that is then certified by its manufacturer. Comments are due July 1.
The Food and Drug Administration posted new and revised versions on March 27 of the following Import Alerts on the detention without physical examination of:
The Food and Drug Administration issued its weekly Enforcement Report for March 27 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
On March 26 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 off on enforcement of its produce safety regulations for certain crops that are rarely consumed raw but weren’t exempted by its 2015 final rule, FDA said in a draft guidance document issued March 27. Hops, wine grapes, some pulses (e.g., dry peas) and almonds did not initially meet FDA’s three-part test used to determine initial exemptions for foods rarely consumed raw, but FDA has since received information that supports finding the crops exempt. “We are considering pursuing rulemaking to address the unique circumstances of these commodities,” FDA said. “In the meantime, FDA intends to exercise enforcement discretion with respect to the Produce Safety Rule for entities growing, harvesting, packing or holding hops, wine grapes, pulse crops, and almonds. This means that we will not expect entities growing, harvesting, packing or holding these commodities to meet any of the Produce Safety Regulation requirements with respect to these commodities.”
The Food and Drug Administration posted new and revised versions on March 25 of the following Import Alerts on the detention without physical examination of:
On March 22 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On March 21 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 March 20 that lists the status of recalls and field corrections for food, cosmetics, tobacco products, drugs, biologics and devices. The report covers both domestic and foreign firms.
The Food and Drug Administration is working on a system for import screening that makes use of artificial intelligence, according to the agency’s fiscal year 2020 budget request. The agency is currently conducting research on the idea with the aim of developing “an intelligent system by applying deep learning for screening and assessing import entry known as DeepSAFE,” FDA said. “This AI system will make the product evaluation and risk-assessment process at the ports of entry more robust.” FDA’s current screening system “uses various rules to determine a risk score that determines if the goods will require a manual review,” it said.