FDA / Regulatory News
A recall is a method of removing or correcting products that are in violation of laws administered by the Food and Drug Administration (FDA). 21 CFR 7 provides guidance so that responsible firms may conduct an effective recall.
Classification
Recalls are classified into a numerical designation (I, II, or III) by the FDA to indicate the relative degree of health hazard presented by the product being recalled.
- Class I – a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
- Class II – a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III – a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Device warning letters plunged nearly 90% over 5 years. An FDA predicts a rebound.
Warning letters are used by FDA to alert a manufacturer it “has significantly violated FDA regulations,” such as misstating what a device is indicated for or having poor manufacturing practices, according to the agency. Warning letters should be sent out within 120 days of a physical inspection of a manufacturer to ensure the evidence underlying it is fresh. FDA can’t issue a warning letter after 120 days of an inspection.
New structure (after re-org) of FDA’s Center for Devices and Radiological Health office will allow to send warning letters in a timely manner and they will begin to pick back up.
Product Recalls and Issues
The FDA has designated a recall of certain GE Healthcare respiratory analyzers used in patient monitoring as Class I, the most serious type of recall.
GE Healthcare began the recall of Carescape respiratory modules and Airway Gas Option NCAiO units in September 2019 because faulty oxygen sensors may cause them to display incorrect patient oxygen levels, according to the agency. Patients could develop long-term high or low blood-oxygen levels, which could result in organ damage, tissue injury, increased chance of infection, or death, the FDA said. There have been no reported injuries or deaths.
