The Food and Drug Administration is proposing to require premarket approval for automated external defibrillator (AED) systems. Should FDA finalize its proposed order, a pre-market approval (PMA) application or notice of development of product development protocol (PDP) will be required before commercial distribution of the class III devices. Comments on the proposed order are due by June 24.
On March 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 issued its weekly Enforcement Report for March 20 that lists the status of recalls and field corrections for food, drugs, biologics, and devices. The report covers both domestic and foreign firms.
On March 19 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 posted presentations from its March 11-12 meeting in Chicago on its Jan. 16 proposed rules on produce safety and preventative controls in human food (see 13010805 and 13010429, respectively. The presentations include overviews, regulatory impact analyses, and FDA educational and technical assistance efforts for each rule. The meeting was the second in a series of three held throughout the country on the proposals. The first was held in Washington, D.C., Feb. 28-March 1, and the next meeting will be held in Portland March 27-28 (see 13020627).
The Food and Drug Administration found violations of Current Good Manufacturing Practice regulations at two of Canadian pharmaceutical manufacturer Apotex’s facilities, and may withhold approval of new drug applications and refuse admission as a result, said FDA in a warning letter. “The evidence suggests that Apotex has failed to implement adequate global and sustainable corrective and preventive actions, and that it continues to manufacture and distribute pharmaceutical product without upholding its legal obligation to comply with CGMP,” FDA said.
A Chinese beauty product manufacturer’s devices will be subject to refusal at the border for failure to register their product with FDA and violations of Medical Device Reporting regulations, said the Food and Drug Administration in a warning letter. According to FDA, Nanhai Meishida Beauty Equipment did not indicate that it had trained employees in MDR procedures. It also markets a “13 in 1 Beauty Instrument” with a “high-frequency function” that induces “sterilization and evaporation,” as well as “hyperemization,” among other things. The company didn’t get permission from FDA in the form of premarket approval or an investigational device exemption, FDA said.
The Food and Drug Administration may place products from Canadian seafood processor Sambro Fisheries on detention without physical examination, effectively refusing imports from the company for violations of seafood Hazard Analysis and Critical Control Point regulations, it said in a warning letter. The company’s HACCP plan doesn’t list hazardous allergens for its tuna, marlin, and mahi-mahi, nor does it define a critical control point of refrigerated storage to control scombrotoxin formation. If the company doesn’t respond in 15 days from receipt of the letter, or FDA deems its response inadequate, FDA may refuse admission.
On March 18 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 March 11-17, 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: