FDA Drug & Device Regulations in 2015: A Year in Review
In 2015, the drug and medical device industries saw a turn toward digital. The U.S. Food and Drug Administration (FDA) established new regulations requiring certain documents to be submitted electronically, including pharmaceutical product applications and adverse event reports for devices. FDA also opened an online database for the public to obtain information about devices.
Read below to learn about these and other points of progress in FDA’s regulation of the drug and device industries in 2015.
- April 20: FDA began to reconsider its regulation of homeopathic drugs. The agency hosted a two-day public hearing to obtain comments from stakeholders. In August, the Federal Trade Commission offered its opinion on the matter.
- May 4: FDA opened the Global Unique Device Identification Database (GUDID) to the public. The GUDID allows users to access data regarding devices which bear a Unique Device Identifier (UDI).
- May 7: FDA published a final guidance document requiring INDs, NDAs, ANDAs, and BLAs to be submitted in Electronic Common Technical Document (eCTD)
- June 6: FDA published a final order reclassifying sunlamp products and UV lamps as class II devices subject to 510(k) requirements.
- June 24: FDA published a draft guidance regarding direct marking of devices with Unique Device Identifiers (UDIs).
- August 10: FDA updated its criteria for accepting 510(k)submissions.
- August 14: FDA’s electronic medical device reporting (eMDR) requirement came into effect. Medical device facilities are now required to submit mandatory adverse event reports electronically.
- August 18: FDA increased the cost of medical device export certificates.