The GMP Letter

A second FDA unique device identifier (UDI) pilot study reveals several issues that are unlikely to be resolved before the FDA publishes a proposed rule in 2011, a new report says.

An increase in serious adverse events tied to automatic external defibrillators (AEDs) may have less to do with faulty manufacturing issues than with industry confusion over the FDA’s medical device reporting (MDR) policy.

As CDRH has once again pushed back the release of its long-anticipated proposed unique device identifier (UDI) rule, devicemakers should look at the Global Harmonization Task Force’s (GHTF) new draft guidance on UDI so they can begin planning their internal systems.

Invacare failed to take adequate corrective action in response to reports of patients being trapped in its medical beds, sometimes resulting in death, a recent Form 483 says.

Abbott Point of Care received a Form 483 related to unreported field actions, environmental controls and process validation protocols.

Defibtech has received a Form 483 after an FDA inspection uncovered issues with its automated external defibrillator (AED) batteries.

OsteoSymbionics, a maker of cranial plate implants, is hoping to resolve a recent warning letter that cited problems with several manufacturing procedures early this year.

Wheelchair manufacturer Gunnell is working with the FDA to clear up its first warning letter.

Failure to establish several basic manufacturing procedures for its disposable CPR mouth barriers resulted in a warning letter to Eagle Health Supplies.

Anchor Products has received a warning letter citing it for a number of issues, including handling of complaints and medical device reports (MDRs).

Steris Isomedix Services has received a warning letter citing it for not establishing adequate procedures involving its relative humidity (Rh) monitors.

Before investigating an existing or potential nonconformity, a devicemaker should have a documented plan in place, a final guidance from the Global Harmonization Task Force (GHTF) advises.

Align Technology, the maker of Invisalign orthodontic devices and appliances, has received a warning letter for failure to report adverse events within 30 days.

WalkMed Infusion has received an FDA warning letter related to its complaint handling and device risk analysis procedures.

An article in the December GMP Letter states that the FDA requires device facility inspections every two years for Class II devices, whereas Canada requires them every five to six years (GMP, December 2010). However, a Health Canada official said manufacturers of Class II, III and IV devices marketed in Canada are subject to quality management systems audits on an annual basis.