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Month: February 2023

Cosmetic Labelling Rules Every Business Should Understand

Cosmetic Labelling

Introduction: Cosmetic labelling is an essential part of developing and marketing cosmetics. Companies must meet government requirements for labelling, including ingredient listings, cautions and warnings, cosmetic claims, directions for use and other information needed for safety and consumer understanding. This guide outlines the necessary requirements of cosmetic labelling in Canada. Understanding Cosmetic Labelling Regulations and

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FDA Draft Guidance Labeling Plant Based Milk Alternatives in 2023

Labeling Plant Based Milk Alternatives

Introduction: The US Food and Drug Administration (FDA) issued draft guidance for comment today to help ensure appropriate labelling of plant-based products marketed and sold as alternatives to milk (plant-based milk alternatives, or PBMA). This draft guidance will provide industry with recommendations that will result in clear labelling, allowing consumers to make more informed purchasing

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Health Canada Latest Draft Guidance (Biologic Regulations, Drug Labelling, NDS/ANDS & Drug Submissions Rolling Reviews)

Health Canada Drug Draft Guidance

  Introduction: Submitting a new drug to Health Canada can be a complex and time-consuming process. This post will provide essential information about the regulations, legal requirements, and specific steps involved in the submission process for new drugs in Canada. Health Canada has been busy lately releasing several draft guidance documents related to drug compliance

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Filing a Medical Device 510(k): Timing and Process Explained

When to File Your 510k Submission

Introduction: A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market a new device that is substantially equivalent to a legally market device. Submitting a 510k to the FDA is an important step for any business or healthcare product that needs to be approved for sale.

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5 Tips to Find the Best Medical Device Regulatory Consultant

FDA medical device consultant reviewing product documentation for compliance

Finding the right medical device regulatory consultant is one of the most important steps to ensure your product meets all FDA requirements and remains compliant with ever-evolving regulations. Whether you are preparing for market launch, renewing an existing product registration, or managing post-market surveillance, expert guidance can make all the difference. The right consultant can

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How to Achieve GRAS Status for Your Ingredient

FDA GRAS compliance guide for food ingredients

If you want to know how to get your ingredient generally recognized as safe (GRAS) by the FDA, you are in the right place. This guide will walk you through the criteria, process, and best practices to help you meet compliance requirements and avoid unnecessary delays.  GRAS designation allows companies to bring products to market

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What Businesses Need to Know About FDA NAC Guidelines

NAC Supplements labeling Requirements

Introduction: On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements that contain N-acetyl-L-cysteine (NAC). NAC is a supplement form of cysteine, a semi-essential amino acid, which was approved by the FDA as a drug in 1963 to treat liver side effects from an overdose of

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How to Navigate Regulatory Requirements for Class III Medical Devices

Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements. Understand the Regulatory Requirements of Class 3 Medical Devices. Class 3 medical devices have the most stringent regulatory requirements when compared to other device classes. To ensure they meet the specific standards set by regulators, manufacturers must thoroughly understand what their obligations are and how to meet them. This includes understanding device labeling, conducting necessary preclinical tests, and designing appropriate clinical trials as well as obtaining marketing authorization from local and international agencies. With little room for error, a company must pay ample attention to meeting these strict regulations. Step-by-Step Guide for Regulatory Compliance Process. A step-by-step guide for Class 3 medical device manufacturers to prepare for and meet regulatory requirements is provided below: 1. Understand the local and international standards and regulations that apply to your product. 2. Perform risk assessments, identify hazards, and assess safety risks. 3. Develop appropriate device labeling information including instructions, warnings, indications, and contraindications. 4. Prepare preclinical tests related to the identified safety risks of the medical device. 5. Run clinical trials by applicable regulations and obtain relevant certification of efficacy, performance, or other features as necessary. 6. Submit marketing authorization applications to local or international agencies if required by applicable regulations or laws. 7. Develop post-marketing surveillance plans as may be needed going forward to ensure continued compliance with standards and regulations applicable to your device. Strategies to Reduce Cost and Time in Compliance Testing. There are strategies to reduce the cost and time associated with compliance testing. For example, the development of a standardized quality manual helps to streamline the process, by providing step-by-step protocols that must be met to achieve conformity with regulatory requirements. Leveraging tools like automated data collection can help bring costs down for conducting tests and checks, where testing has been pre-certified as meeting standard requirements. Additionally, engaging external compliance teams or consultants early in the process can help identify any potential problems quickly and provide advice on which steps are critical to addressing quality management issues. Assessing the Role of Third-Party Certifiers in Regulating these Devices. Third-party certifiers are an invaluable tool in the regulation of Class 3 medical devices. Not only do they allow manufacturers to have a comprehensive overview of the entire product development cycle and all its stages, but they also aid in certifying that requirements have been met as outlined by regulatory authorities. Additionally, they can provide valuable insights into which materials must be considered during the production process that may not necessarily be required by regulations, but would improve safety or efficacy. Ultimately, certification from third-party entities is an essential component for Class 3 medical devices to fully comply with applicable standards and regulations. Guidelines for manufacturers for Managing Risk and Adverse Events. The risk of adverse events is an ever-present reality for medical device manufacturers. Therefore, it is important to have a robust management system in place for risk and adverse event assessment, reporting, and monitoring to minimize the potential impact these may have on safety and efficacy. Manufacturers should clearly define criteria within product development plans to ensure appropriate assessments are taken during each product’s entire life cycle. This includes a systematic approach to suspending, withdrawing, or replacing devices deemed unsafe or ineffective due to adverse events. Additionally, manufacturers should be prepared to respond quickly and effectively whenever an adverse event or complaint is reported.

Introduction: Class 3 medical devices are subject to the highest level of scrutiny and require special attention when it comes to meeting their regulatory requirements. This article will discuss what it takes for Class 3 medical devices to meet these stringent requirements. Class 3 medical devices are especially complex and pose the highest risk to

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What Does It Mean to be GFSI Certified in an FSMA Environment?

GFSI Certified in an FSMA Environment

Introduction: FSMA stands for the “Food Safety Modernization Act” which is a set of laws enacted by the US government to ensure food safety and decrease the risk of foodborne illness. Congress enacted FSMA in response to dramatic changes in the global food system and in our understanding of foodborne illness and its consequences, including

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