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Description:Registrar Corp provides US FDA compliance assistance to companies in the food and beverage medical devices cosmetics drug and tobacco industries
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+1-757-224-0177 MyFDA Login English +1-757-224-0177 English -- Select Your Language Español 中文 Italiano Français Deutsch Português Login To MyFDA Username Password Login FDA Registration Solutions News About Us Contact Us EN 24/7 LiveChat Call Us 2019 in Review- Medical Devices and Drugs Posted on December 31, 2019 . Posted in Drugs , Medical Devices 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. In September 2019, FDA removed thousands of listings that contained outed or incomplete information from its database. 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 . Continue Reading 2019 in Review: Rise in FSMA Enforcement for Food and Beverage Facilities Posted on December 31, 2019 . Posted in Food & Beverages , FSMA With most deadlines having passed from the Food Safety Modernization Act (FSMA), the U.S. Food and Drug Administration (FDA) ramped up efforts this year in enforcing the new regulations. Whether it be through inspection violations or warning letters, FDA sought to fully implement FSMA regulations. See some of the year’s highlights below. FDA Began More Actively Enforcing FSMA regulations FDA’s inspection data reported 278 citations to importers without an FSVP, up from 108 the previous year. FDA also cited hundreds of facilities for having issues with their Hazard Analysis and Risk-Based Preventive Controls (HARPC) Food Safety Plans. These citations ranged from failing to have a HARPC Food Safety Plan, not identifying hazards that require a control, or not having a Preventive Controls Qualified Individual (PCQI) write the plan as required. With most of the deadlines having passed, some several years ago, it should be expected that FDA will continue to enforce these rules more heavily. FDA Removed 20% of Food Facility Registrations after Renewal Period FSMA requires food facilities to renew their FDA registration between October 1 and December 31 of every even numbered year. FDA routinely removes facilities from its database that fail to renew. FDA removed over 47,000 companies at the beginning of 2019. FDA considers registrations that are not renewed to be expired. Having an expired registration prohibits a facility from selling and distributing their products in the United States. The next renewal period will take place between October 1 and December 31 of 2020. Intentional Adulteration Deadline Passed Under FSMA, facilities must designate a Qualified Individual to develop mitigation strategies to protect food from intentional adulteration via a Food Defense Plan. The deadline for facilities with more than 500 full-time equivalent employees to comply passed on July 26, 2019. Businesses with less than 500 full time equivalent employees must comply by July 26, 2020. FDA released a guidance to assist facilities in creating their Food Defense Plans . The guidance supplies several methods to streamline the process of creating a plan. FDA Announced Higher Re-Inspection Fees This year, FDA announced they would raise the fee for re-inspections conducted in 2020. Although there is no fee for routine inspections, FSMA gives FDA authority to collect fees when FDA re-inspects a facility due to compliance issues. The fee for foreign facilities increased to $301/hr and $258/hr for domestic facilities. FDA Issued Warning Letters for Preventive Controls and FSVP Violations This year, FDA started issuing warning letters to companies with compliance issues in regards to FSMA violations, most frequently involving Preventive Controls and FSVP . When the deadlines first passed for these regulations, FDA offered a grace period in which they sought to educate facilities as to what would be expected of them regarding these new rules. However, it is clear that FDA is shifting from the educational phase to enforcement. A warning letter is an official message from FDA citing a compliance violation. Generally, facilities have 15 business days to respond with solutions to the violations. Expect more of these letters to be issued for FSMA violations in 2020. Final Preventive Controls Deadline Passed The last of the Preventive Controls deadlines (for very small animal food facilities) passed this year . With all the deadlines having passed, it will now be expected for facilities to comply with Preventive Controls rules, and any deviation can result in regulatory action from FDA. The overall theme of 2019 was increased enforcement of FSMA regulations. Regi...
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