Recently the FDA (United States) has released its latest List of Recognized Consensus Standards & the EU (European Union) has released updated lists of Harmonized Standards for the MDD (Medical Device Directive), the AIMDD (Active Implantable Medical Device Directive), and the IVDD (In-Vitro Diagnostic Directive).
On 15 Jan ’13 the FDA issued a notice in Federal Register for the Recognition List # 30. The notice in the Federal Register said: “FDA maintains the Agency’s current list of FDA recognized consensus standards in a searchable database…FDA will incorporate the modifications and minor revisions described in this notice into the database and, upon publication in the Federal Register, this recognition of consensus standards will be effective. FDA will announce additional modifications and minor revisions to the list of recognized consensus standards, as needed, in the Federal Register once a year, or more often, if necessary.”
Other resources that you can find out more about this subject:
RAPS Regulatory Focus article of 15 Jan 2013
CDRH’s Standards Program / Standards Management Staff webpage
On 24 Jan ’13 the Official Journal of the European Union published updated lists of Harmonized Standards under their respective Directives for the:
MDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*
AIMDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*
IVDD (OJ published updated list of Harmonized Standards) and the consolidated list of Harmonized Standards*
* – All of the consolidated lists of Harmonized Standards have a note that indicate that these are for reference only and are not the legal documents. A repeat of the note for these Directives is below:
“The summary list hereunder is a compilation of the references of harmonised standards which have been generated by the HAS (Harmonised standards) database. This IT application HAS automates the process of the publication of the references of harmonised standards in the Official Journal of the European Union. Although the list is updated regularly, it may not be complete and it does not have any legal validity; only publication in the Official Journal gives legal affect.”