In 2019, we saw the U.S. Food and Drug Administration (FDA) enhance its enforcement of drug and device safety by removing eligibility for many devices from a program intended for low-risk products, removing thousands of drug listings from its database, and more. Our 2019 round up of device and drug regulations will cover these updates and more.
Final Monograph for OTC Sunscreen Products
FDA published a proposed rule that would alter the way sunscreen products are regulated in the future. These changes include updates to which ingredients are generally recognized as safe and effective (GRASE), updating the GRASE status of different dosage forms of sunscreen (oils, lotions, creams, etc.), changes to the way sunscreens are labeled, and recognizing sunscreen-insect repellent combinations as not GRASE.
These provisions are not final; however, they signal upcoming changes to the way sunscreen products will be regulated in the United States.
FDA Agreed to Share Drug Inspection Data with the European Union (EU) Under a Mutual Recognition Agreement (MRA)
FDA and the EU established the MRA to streamline drug establishment inspections between the two agencies to avoid redundant inspections and allow greater efficiency within the organizations. The agreement allows both agencies to utilize each other’s inspection data with the goal being to cut down on routine inspections. Both agencies will still be conducting inspections in each other’s countries, but it is expected to be less common.
FDA Removed Thousands of Drug Listings from its Database
FDA requires all drug manufacturers marketing drug products in the United States to both register their establishments and list the individual drug products made at those establishments. FDA requires biannual reporting on drug listings, in June and December. If no changes or updates are made to a listing during the reporting period, FDA requires manufacturers to submit a blanket no change certification for these listings during the annual registration period. Failure to do so leads FDA to consider the listing outdated or incomplete.
FDA Ramped up Enforcement of Unapproved Drug Products
FDA added or updated hundreds of products and companies to it Import Alert this year for marketing unapproved drug products. If food, dietary supplements, or cosmetics make unapproved medical claims, it can lead FDA to consider them as drug products, and thus requiring them to follow drug regulations.
FDA may consider claims made on a product’s advertising or websites to be part of its labeling. It remains important to be aware of the claims your product makes so as not to have it fall under FDA’s drug regulations unintentionally.
FDA Updated Product Code Eligibility for the Voluntary Malfunction Summary Reporting (VMSR) Program
FDA changed the eligibility status of several medical device product codes for their VMSR program. This program allowed certain manufacturers of low risk medical devices to submit Medical Device Reports (MDRs) in batches during every quarter to reduce the total number of MDRs they would have to send. The change requires some companies that previously participated in the program to now submit individual reports.
We will continue to inform industry of updates to FDA regulations and enforcement throughout 2020. Subscribe to our blog to receive future updates by email. Registrar Corp offers FDA compliance services for medical device and drug facilities, including FDA registration, labeling assistance, and more. For assistance with FDA regulations, call us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.