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Graphic Controls Data Recording failed to inform the FDA of several complaints about its automatic external defibrillator (AED) pads malfunctioning in a way that could have caused serious injury or death to patients, agency investigators found during an inspection of the company’s Buffalo, N.Y. facility. Read More
A federal judge has issued a preliminary injunction blocking Charles River Laboratories (CRL) from harvesting the blood of horseshoe crabs for use in bacterial contamination tests for drugs and vaccines — a move that could lead to a shortage of the much-needed tests. Read More
May 26 marked the effective date of the EU’s Medical Device Regulation (MDR), requiring new devices to comply before they can be sold in the bloc — although many currently certified devices have another three years to comply. Read More
The European Commission has proposed stiffer regulations for products that rely on artificial intelligence (AI) and some medical devices would be considered “high risk” under the proposal. Read More
Several House Democrats have urged the Department of Health and Human Services (HHS) to reverse a Trump administration policy that removed FDA premarket review requirements for COVID-19 laboratory-developed tests (LDTs). Read More
The FDA said it plans to gradually resume its on-site drugmaker inspections beginning in July with the intent to be back to normal operations by September. Read More
The FDA issued a final rule that updates the descriptions of eight software functions that don’t meet the definition of medical device under the 21st Century Cures Act, effectively removing certain software from regulation. Read More
The European Commission’s Medical Device Coordination Group issued guidance for devicemakers of high-risk Class D in vitro diagnostics on applications during the transition period for the EU Invitro Diagnostic Regulation (IVDR) which will go into effect on May 26, 2022. Read More
China’s National Medical Products Administration reported that in 2020, the country’s medical device adverse event monitoring system received a total of 536,055 medical device adverse event reports, an increase of more than 35 percent on the previous year. Read More
Validation procedures for testing finished devices and software validation procedures related to Koko’s Px pulmonary function testing devices were observed to be inadequate during a Jan. 5-25, 2021 FDA inspection of the firm’s Longmont, Colorado facility. Read More
Failure to adequately validate its purified water system resulted in possible contamination of several lots of Sunstar Americas’ oral hygiene products, the FDA discovered during a Jan. 12 to Feb. 18 inspection of the firm’s Schaumburg, Illinois manufacturing facility. Read More