FDA has published its list of spring modifications to the list of standards the agency uses in premarket reviews.
Manufacturers can use the list of recognized standards to ensure conformity with consensus standards. Updates to the list are made in alliance with ISO and ASTM along with industry collaboration from organizations such as AAMI.
FDA publishes the list three to four times per year with major updates published in the spring and fall. The spring 2016 standards list features 32 modifications that include the addition of standards not previously recognized by FDA.
The standards cover an array of device areas including cardiology, anesthesia, quality systems and risk management, electrical safety, surgery, IVD’s, medical materials, orthopedics, radiology, sterility, informatics and tissue engineering.