The Food and Drug Administration intends to adopt a non-enforcement stance for controls on medical device data systems, it said in a draft guidance posted June 20 (here). Under the policy, if adopted, FDA would not “enforce compliance with the regulatory controls, including registration and listing, premarket review, postmarket reporting and quality system regulation for manufacturers of these types of devices,” it said. Comments on the draft guidance are due Aug. 25, according to a concurrent Federal Register notice (here).
On June 23 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 20 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 is allowing more time for comments on its proposal to extend its current restrictions on cigarettes and smokeless tobacco so they also apply to electronic “e-cigarettes,” cigars, pipe tobacco, nicotine gels, hookah tobacco, and nicotine dissolvables. The proposed rule issued by FDA in April would set requirements for registration, FDA review, and health warning labels on e-cigarettes and other tobacco products (see 14042426). Comments are now due Aug. 8.
Correction: The Food and Drug Administration is loosening controls on nonabsorbable expandable hemostatic sponges for temporary internal use by reclassifying them as Class II medical devices (see 14061615).
On June 19 the Food and Drug Administration posted new and revised versions of the following Import Alerts on the detention without physical examination of:
On June 18 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 June 18 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 announced the reclassification of blade-form endosseous dental implants as Class II medical devices subject to special controls. The dental implants were previously classified in Class III and required premarket approval. The reclassification will take effect July 18; Although the devices will no longer need FDA approval, the devices will still be subject to premarket notification requirements, as well as certain extra "special controls" related to design characteristics, testing, biocompatibility, and labeling..
The Food and Drug Administration threatened Chinese and India drug makers with import refusal in two recent warning letters. In a letter dated June 10 (here), FDA told Tianjin Zhongan Pharmaceutical of China that it needs to correct violations of current good manufacturing practice (CGMP) requirements or else face an import alert on its active pharmaceutical ingredients (APIs). In a separate letter dated June 16 (here), FDA told Apotex Pharmachem India that it will continue to refuse imports of APIs from the company, also for violations of CGMP requirements.