FDA Bar Code Label Rule for Drugs and Biologics

FDA issued a final rule requiring bar code labels for Human Drugs and Biologics. This rule discusses the information content of the labels and computer use of these labels in health care. Specific changes are made to the Drug (201), Blood (606) and Biologics (610) regulations to implement this labeling requirement. A copy of the rule including the preamble is at the link provided. Effective date of the rule is April 26, 2004 and drugs and biologics receiving approvals on or after that date must comply with the rule within 60 days after the drug approval date. Products approved prior to that date must comply by April 26, 2006.

SoftwareCPR Training Courses:

IEC 62304 and other Emerging Standards Impacting Medical Device Software

Being Agile & Yet Compliant

ISO 14971 SaMD Risk Management

Software Risk Management

Medical Device Cybersecurity

Software Verification

IEC 62366 Usability Process and Documentation

Or just email training@softwarecpr.com for more info.

Corporate Office

15148 Springview St.
Tampa, FL 33624
USA
+1-781-721-2921
Partners located in the US (CA, FL, MA, MN, TX) and Canada.