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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
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 issued new recommendations on 510(k) submissions for peripheral vascular atherectomy devices used to remove plaque from diseased arteries. Read More
May 26 marks 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
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
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
AdvaMed is urging the Centers for Medicare and Medicaid to implement the Medicare Coverage of Innovative Technology (MCIT) rule without delay after CMS announced it would postpone a final ruling on the regulation that would provide immediate national coverage for four years for any new device or diagnostic designated as a breakthrough technology. Read More
The FDA has announced that it will conclude its Quality in 510(k) Review Program pilot after May 30 and will no longer accept submissions after that date, directing companies to consider using its electronic Submission Template and Resource (eSTAR) pilot program instead. 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 Center for Devices and Radiologic Health may not meet its Medical Device User Fee Act (MDUFA) review goals during the pandemic, two senior officials warned. Read More