Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Guidance for industry and FDA staff. Comments can be submitted.

This content was submitted directly to this website by the supplier.

May 21st, 2021

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages

This guidance describes the Agency's policy regarding the prohibition against providing National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers on device labels and device packages set forth at 21 CFR 801.57(a)-(b).

As is described, FDA does not intend to object to the use of legacy FDA identification numbers on device labels and packages for finished devices manufactured and labeled prior to September 24, 2023.

In addition, this guidance addresses requests for continued use of FDA labeler codes under a system for the issuance of unique device identifiers (UDIs).

Enforcement Policy Regarding Use of National Health Related Item Code and National Drug Code Numbers on Device Labels and Packages Guidance for Industry and Food and Drug Administration Staff

Download your free copy of the “Asset Reliability Roadmap for the Consumer Products Industry” at www.opxleadershipnetwork.org/maintenance/download/asset-reliability-roadmap.

Untap the Hidden Potential From Your Asset Base

The upside to asset reliability is controlling unit costs and even reducing them, improving operational effectiveness as a dependable supply chain partner, and finding that hidden plant within operations that can defer major capital expenditures.

Buitoni President And Ceo Graham Corneck

Buitoni Foods Appoints Graham R. Corneck as President and CEO

Corneck will be replacing Peter Wilson, who will rejoin Brynwood Partners as managing director and chairman of Buitoni Foods.

Heinz Ketchup’s New Dispensing Valve | Materials Shortages Rankle Bev Industry

Iconic Heinz Ketchup switched to a new dispensing valve and closure that will make the pack more sustainable. Meanwhile, beverage producers struggle with materials shortages.

Sm Graphic Matt

unPACKed Podcast: A 1st Look At PACK EXPO 2022

Listen to editors from PMMI Media Group lay out the top trends and innovations attendees can expect to see at PACK EXPO East 2022.

Smucker Divests Private Label Dry Pet Food Business

The company has sold the business segment to Diamond Pet Foods as a part of its continued portfolio optimization focusing on other areas of its petfood and pet snacks business.

Ofer Shoham, CEO, Bio-Fence

Polymer Surface Treatment Improves Sanitation Efficiency

Start-up company Bio-Fence has created an innovative polymer that, when added to a topcoat/paint, binds disinfectant to the surface, increasing sanitation efficiency and eliminating pathogenic bacteria.

Lactalis, Kraft

Lactalis Canada Adding Kraft Heinz Grated Cheese Business to Portfolio

The transaction reinforces the company’s long-term investment in the food processing sector and marks its foray into the grated cheese business category, a first for the dairy leader.

Pabst Brewing Names Paul Chibe as New CEO

The former Ferrero Group senior executive succeeds Eugene Kashper, who will remain Pabst’s chairman of the board of directors and continue to play an active role in the business.

The FlexiBulk can fill bags in baskets while other bags are being pressed and unfilled.

Flexible HPP System Processes Both Bulk and Packaged Products

FlexiBulk high pressure processing equipment from JBT Avure can handle bulk bags in one basket while processing individually packaged products in another, improving speed and pack efficiency.

The CIP system has the capacity to clean half the plant, covering 21 different circuit points, and fits in a very confined space in a dedicated CIP room.

Kraft Mac and Cheese Modernization

Completed on time during the height of the pandemic, a multi-line expansion project for Kraft Heinz’s macaroni and cheese product increased production output without disrupting the Wausau plant’s existing production schedule.

Heinz Ketchup 3

Kraft Heinz Ketchup Packaging Adopts New Dispensing Valve Tech

Iconic Heinz Ketchup recently received a valve closure makeover. An award-winning valve system, the recyclable SimpliCycle from Aptar Food and Beverage, will be found in several Kraft Heinz brands by the end of the year.

American Peanut

American Peanut Growers Group Expanding Operations in Georgia

The project will help the group increase the manufacture of peanut paste, granules, peanut butter, and roasted peanuts to meet rising peanut consumption, which is at an all-time high.

unPacked with OEM podcast

unPACKed with OEM Podcast: Packaging and Processing's Gender & Race Wealth Gap

Listen to OEM Editor-in-Chief Stephanie Neil's discussion with Below the Line President Jill Miller about Miller's goal to level the playing field for women and people of color in packaging and processing.

Gareth Williams, Nukon

Three Ways Artificial Intelligence is Changing Food and Beverage Manufacturing

Artificial intelligence can aid in remedying some of the pain points in manufacturing, such as maintaining consistent product quality, need for predictive maintenance, and demand for actionable insights from sensor data.

Lakeshore Technologies is known for its ability to solve metal contamination problems where others have failed.

Metal Contamination Removal Is Key to Success for Toll Processor

Becoming known for its ability to find and remove metal contaminants from customer products, Lakeshore Technologies relies heavily on metal detectors and magnetic separators from Eriez.

Solaris Porto Mantovano, Italy Location

Donaldson Company Acquires Solaris Biotechnology

The acquisition will position Donaldson to provide more comprehensive solutions to food and beverage customers and expand its access to biopharma and other key life sciences markets.

Del Monte Upcycled

Del Monte Foods Helps Lead Upcycled Food Movement

The company has re-directed 600,000 lb of surplus green beans, the food industry’s first canned vegetable product to be Upcycled Certified, nourishing people while reducing greenhouse gas emissions.

Unilever Poised to Sell Tea Business

The company has announced its intention to sell its world-leading tea business ekaterra and its assets to CVC Capital Partners Fund VIII for over $5 billion.

Mondelēz Investing $122.5 Million to Expand Virginia Operations

The investment will support the company’s manufacturing operations, enable the existing site to house a high-speed, modern Oreo production line, and play an integral role in creating a best-in-class integrated supply chain.

Smucker Building New Manufacturing Facility and Distribution Center in Alabama

The company will invest $1.1 billion to accelerate Smucker’s Uncrustables sandwiches growth, demonstrating its commitment to meet increasing demand for the highly successful product and deliver on its strategy to focus on growth brands.

More in Home

Beverage Industry Trends: Consumers, E-Commerce, and Global Market Challenges | How to Successfully Adopt AI Applications

Consumers are demanding more of today’s beverage market, but supply chain issues and labor shortages are creating challenges. Also on today's Take Five video: Industry expert provides insight on how to efficiently apply AI to facilities.

JBS Entering Cultivated Protein Market With Acquisition of BioTech Foods

As a part of the move, the company will be building a new production plant in Spain, which will scale up production, and a research & development center in biotechnology and cultivated protein in Brazil.

Conagra Brands Recognizes 10 Facilities as 2021 Zero Waste Champions

The honored U.S. and Canadian frozen, snacks, international, and grocery manufacturing facilities diverted more than 95% of materials from landfill through innovative recycling and waste reduction measures.

Linxis Group President and CEO Tim Cook

Linxis Group Names Tim Cook as President and CEO

Shick Esteve North America President Blake Day appointed as CEO of its Kansas City, Mo. and Rians, France facilities.

Heineken Announces Intent to Acquire Control of Distell and Namibia Breweries

The transaction will combine the three businesses to create a regional beverage champion, with a significantly strengthened, complementary route to market in South Africa and Namibia, to pursue further growth opportunities across southern Africa.

Katz Gluten Free creates allergy-friendly baked goods for all kinds of dietary restrictions.

Data Insights Give Small Baked Goods Specialist Handle on Market

Finding it difficult to gain visibility into its sales channel without the kinds of resources a larger food maker might have, Katz Gluten Free found answers from the Crisp programmatic commerce platform.

Sergey Yeskov, Molson Coors Incoming Europe President and CEO

Molson Coors Names Sergey Yeskov as Incoming Europe President and CEO

Simon Cox, current CEO and Europe president, is retiring at the end of the year after more than three decades in the beer industry, including 16 years with Molson Coors.

Sridhar Sudarsan, chief technology officer at SparkCognition

Proper AI Application Fuels Food and Beverage Innovation

The collection of actionable data generates insights to optimize production, reduce downtime, and increase overall efficiency, and can be scaled throughout a company’s infrastructure.

Meat Institute Announces New Climate Targets

The group has released new targets, alongside its sustainability framework launched through the Protein PACT for the People, Animals, and Climate of Tomorrow.

Hershey to Purchase Dot’s Homestyle Pretzels and Pretzels Inc.

The acquisition of Dot’s Homestyle Pretzels and Pretzels Inc. will complement Hershey’s growing salty snacking portfolio and create an opportunity to reach new consumers in new occasions, advancing Hershey’s snacking powerhouse vision.

Tesco's 2021 Preferred Materials and Formats for UK Packaging

Tesco Taking the Lead on Sustainable Packaging Choices for UK Suppliers

Brands who want space in this top UK retailer’s stores need to comply with preferred packaging material and format suggestions, which are driven by material recyclability.

Ekaterra Targets Net Zero Emissions By 2030

Unilever Tea Division Targets Net Zero Emissions by 2030

Ekaterra, the tea division of Unilever, has announced its plans to become climate and nature positive, while working to make the entire tea industry more sustainable for the planet and people.