The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view. Thomas addressed an audience at the Food and Drug Law Institute’s annual enforcement conference here in the nation’s capital, acknowledging that the proposed alignment of the Quality System Regulation – also known as Part 820 – with ISO 13485 is no light lift.
The U.S. FDA’s recent warning letter to Danvers, Mass.-based Abiomed Inc., may have come across as an enforcement outlier in the context of the agency’s controversial final guidance for clinical decision support (CDS) products.
The unique device identifier (UDI) might not be the most exciting U.S. FDA enforcement mandate for most of regulated industry, but the FDA’s Keisha Thomas indicated that compliance is less than adequate in the agency’s view.
The COVID-19 pandemic took a huge bite out of the U.S. FDA’s ability to conduct inspections in a timely manner, but the FDA’s Douglas Stearn said the agency has nonetheless ramped up these activities.
The U.S. FDA’s draft rule for regulation of lab-developed tests (LDTs) was accorded a mere 60 days for comment, but nonetheless drew support from a number of stakeholders, including Foundation Medicine of Cambridge, Mass.
The U.S. FDA’s advisory hearing on multi-cancer detection (MCD) tests suggests that the premarket requirements for these tests will be rigorous, if only because the agency stated at the outset of the hearing that it sees these tests as class III devices. However, the advisory committee also suggested that a registry be established to track outcomes for these tests, a requirement that is likely to prove expensive and time-consuming to fulfill.
The U.S. Federal Trade Commission announced Nov. 21 that it has obtained a civil monetary penalty in the amount of $700,000 from CRI Genetics LLC, an enforcement action taken under the agency’s policy for biometrics information.
The U.S. Federal Trade Commission is clearly a more activist agency of late, although much of that activism has been around mergers and acquisitions. The latest FTC move, however, deals with investigative authorities that will be applied toward artificial intelligence (AI), which Katie Bond of Keller & Heckerman LLP said will give the agency considerable powers of discovery regardless of the merits of the enforcement action.
The U.S. FDA advises health care providers (HCPs) to avoid using Monoject syringes distributed by Cardinal Health with syringe pumps or patient-controlled analgesia (PCA) pumps because of incompatibilities between the Monoject interface and the pumps.
The U.S. FDA’s predetermined change control program (PCCP) is the talk of the med-tech town, but this novel regulatory mechanism has its limitations, said Cassie Scherer, senior director for digital health policy at Medtronic plc.
