FDA Updates List of Consensus Standards
Check this list to be sure you are consulting the most up-to-date medical packaging standardï¿½or find one you havenï¿½t used before.
In September 2008, FDA published an updated list of recognized consensus standards in the Federal Register. Many of these relate to packaging, guiding medical device manufacturers through testing and materials selection processes. The document may also be accessed at www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/cdrhnew.cfm.
FDA is allowed “to recognize consensus standards developed by international and national organizations for use in satisfying portions of device premarket review submissions or other requirements,” charged so under the FDA Modernization Act of 1997 (FDAMA), which amended section 514 of the Federal Food, Drug, and Cosmetic Act (the act) (21 U.S.C. 360d). Manufacturers therefore may “elect to declare conformity with consensus standards to meet certain requirements for medical devices,” FDA states.
PMP News checked in with a few standards committee members to see whether there were any particular updates of note.
For instance, Hal Miller, chairman of Committee F02 on Flexible Barrier Packaging and president of PACE Solutions LLC, reports that the listing simply updates the ASTM standards to their current edition. He advises that users pay particular attention to “the devices and processes affected, extent of recognition, and relevant guidance sections” of each standard. “For instance, the relevant guidance section of ASTM F1886 on visual inspections states that visual inspection may not be used as the only method of package integrity testing during process validation studies,” Miller notes.
Some standards have been given new recognition numbers. In the table below, standards issued a new number will display the old number in parentheses.
One new packaging-related standard has been recognized: ASTM F17–07a Standard Terminology Relating to Flexible Barrier Packaging, Recognition No. 14–255.