2017 in Review – U.S. FDA Medical Device and Drug Regulations
The medical device and drug industries saw numerous regulatory developments in 2017. The U.S. Food and Drug Administration (FDA) introduced new requirements, fees, deadline extensions, and exemptions. Below, Registrar Corp provides an overview of regulatory highlights this year.
FDA Removed Medical Device and Drug Establishments that Did Not Register for 2017
Medical device and drug establishments that failed to properly renew their registrations for 2017 were removed from FDA’s active registration database. The Agency will likely do the same in 2018. Marketing medical devices and drugs without a valid registration is a prohibited act that may be met with seizure and injunction.
FDA Extended the UDI Compliance Date for Class I Devices to 2020
FDA issued a letter in June announcing its intention to extend the universal device identifier (UDI) compliance dates for class I and unclassified devices. The letter proposes to push the UDI labeling compliance date for these devices to September 24, 2020.
FDA Exempted Certain Class II Devices from 510k
In July, FDA exempted certain class II medical devices from premarket notification (510k) requirements. The exempt devices “are sufficiently well understood and do not present risks that require premarket notification review to provide a reasonable assurance of safety and effectiveness.” View a list of the exempt devices here.
The Compliance Date Passed for the Consumer Antiseptic Wash Final Rule
As of September, over-the-counter (OTC) consumer antiseptic washes containing any of nineteen certain ingredients are not permitted to enter interstate commerce without approval of a new drug application (NDA). FDA made this determination after discovering there was insufficient evidence to support the ingredients’ safety and effectiveness for their intended use.
FDA Published FY 2018 User Fees for Medical Devices and Generic Drugs
The Medical Device User Fee Amendments (MDUFA) and Generic Drug User Fee Amendments (GDUFA) were reauthorized for fiscal year (FY) 2018. The amendments introduced differences in rates from FY 2017, as well as new types of fees for certain facilities and submissions.
FDA Introduced a New Verification Requirement for U.S. Agents of Medical Device Establishments
The U.S. Agent of medical device establishments located outside of the United States is now required to confirm this role with FDA. Agents must accept their designation through the FDA Unified Registration and Listing System (FURLS). If the Agent does not respond to a verification email within ten days, the establishment will need to designate a new Agent.
FDA Introduced Annual Certification Requirement for Unchanged Drug Listings
The 2017 registration renewal period introduced a requirement for drug establishments to submit a “blanket no-change” certification for drug listings that did not receive any changes to data or labeling during the year. Certifications must be submitted in structured product labeling (SPL) format.
FDA Published Final Guidance for UDI Direct Marking Requirements
In November, FDA issued a final guidance to clarify a device labeler’s responsibilities for UDI direct marking requirements. Class II devices must comply with direct marking requirements by September 24, 2018. During a December webinar, FDA stated that they do not intend to enforce these requirements for class I and unclassified devices until September 24, 2022.
FDA Issued a Final Rule on the Safety and Effectiveness of Triclosan in Health Care Antiseptics
FDA finalized a rule prohibiting the use of Triclosan and 23 other active ingredients in OTC antiseptics for health care environments. After December 20, 2018, health care antiseptics containing these ingredients will not be permitted to enter interstate commerce without FDA approval of an NDA.
As we cross into 2018, Registrar Corp will continue to keep the medical device and drug industries informed about important FDA regulations. For assistance with FDA requirements in either industry, call us at +1-757-224-0177, or chat with a Regulatory Advisor 24/7 at www.registrarcorp.com/livehelp.