The GMP Letter

The International Medical Device Regulators Forum late last month unveiled its long-awaited plan for device identification, pushing for a “highly interoperable” and harmonized system to globally track medical devices.

An FDA advisory panel tentatively suggested the agency look to current quality systems regulations to improve disaster preparedness for devicemakers, rather than writing new regulations.

Device trade groups are pushing for several harmonization provisions, including a single-audit system, to make it into the planned Transatlantic Trade and Investment Partnership (TTIP) Agreement.

Strong buy-in at the top is essential to developing and maintaining a successful compliance program, experts told attendees at the Medical Device Manufacturers Association meeting last month.

To comply with drug-side reserve requirements, makers of single-entity combination products need to retain samples of the complete product, an expert says.

SCM True Air Technologies, a maker of therapeutic mattresses, fielded a four-observation Form 483 related to its handling of complaints and manufacturing changes.

An FDA Form 483 to Alma Lasers documents problems with complaint records and procedures for reviewing and evaluating complaints.

ACell, a maker of tissue and organ repair products, received an FDA Form 483 noting that several design inputs were identified from scientific articles and promotional materials for similar devices.

The International Medical Device Regulators Forum (IMDRF) has issued two draft standards on harmonized audit criteria and training requirements for both regulatory agencies and third-party auditing organizations.

The FDA has warned Baxter Healthcare for marketing its SIGMA Spectrum Infusion Pump with Master Drug Library without an approved application or IDE.

Abbott is recalling U.S. supplies of its FreeStyle InsuLinx blood glucose meters, due to a problem with readings at very high glucose levels — the second such recall by a diabetes product maker in a month.

An Italian manufacturer of laser devices was hit with a Form 483 and warning letter after an FDA inspection detected multiple problems with the company’s documentation practices.

An FDA warning letter to CORPAK MedSystems calls out the company’s handling of defective stylets and complaints related to their use.

The FDA has warned a Finnish maker of x-ray devices that lacked procedures on design control, quality audits and training.