Top Reasons 510(k) Submissions for Dental Devices Get Rejected (And How to Avoid Them)
Few things set back a product launch more painfully than a rejection letter from the FDA. When your 510(k) submission
... Read more May 10, 2026
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[blog_list]
How to Get GRAS Status for an Extract: What the Process Actually Involves
Pursuing GRAS status for an extract is not the same as pursuing it for a whole botanical or a well-characterised food ingredient. The
... Read more May 10, 2026
Understanding the SaMD Regulatory Pathway in Canada and the United States
Software that diagnoses, monitors, or treats a health condition carries a different kind of regulatory weight than a physical device. If
... Read more April 25, 2026
Whole Ingredient vs Extract GRAS Requirements: What Changes and Why It Matters
The question of whole ingredient vs extract GRAS requirements comes up constantly when companies formulate with botanicals, functional ingredients, or
... Read more April 19, 2026
What to Do (and Avoid) in Your FDA 510(k) Submission Process
Getting an FDA 510(k) submission right the first time is one of the most consequential steps in your medical device’s path to market.
... Read more April 13, 2026
FDA Takes New Steps to Improve Gluten Ingredient Disclosure in Foods
On January 23, 2026, the U.S. Food and Drug Administration (FDA) announced new actions aimed at improving how a gluten ingredient is disclosed on
... Read more January 29, 2026
FDA Releases Human Food Program 2026 Priorities For Food Businesses
The U.S. Food and Drug Administration (FDA) has released its priority deliverables for 2026 under the Human Food Program, outlining
... Read more January 27, 2026
Achieving GRAS Status for a Probiotic: A Step-by-Step Approach
When you are trying to bring a probiotic ingredient to the U.S. market, one of the first questions you will
... Read more January 18, 2026
FDA Removes Key Barrier to Real-World Evidence for Drugs and Medical Devices
The U.S. Food and Drug Administration has announced a change to how it evaluates real-world evidence in regulatory reviews. In a
... Read more December 17, 2025
U.S. Congress Introduces Bill Requiring Warning Labels And Ad Limits For “Junk Food”
Members of the U.S. House of Representatives have introduced the Childhood Diabetes Reduction Act of 2025. The bill would, in
... Read more December 17, 2025
Understanding the Difference Between a GRAS Notice and Self-Affirmed GRAS
Companies introducing new food ingredients into the United States must demonstrate that those ingredients are safe under their intended conditions of use.
... Read more December 13, 2025
Understanding GRAS Notice Delays in the FDA Review Process
Navigating the U.S. Food and Drug Administration (FDA) review process can be challenging for food and ingredient companies, especially when timelines do
... Read more December 8, 2025
Understanding GRAS and FEMA GRAS for Food and Flavor Compliance
The difference between GRAS and FEMA GRAS is a common point of confusion for companies working with food and flavor ingredients. When
... Read more November 30, 2025
How to Reduce Costs Throughout Your FDA GRAS Project
FDA GRAS projects can feel overwhelming, especially when you are trying to balance timelines, research needs, and budget pressures at
... Read more November 26, 2025
New 2025 Senate Bill Would Mandate FDA Notification for All GRAS Ingredients
A new proposal in the U.S. Senate could bring mandatory GRAS notification to the forefront of food regulation, changing how
... Read more November 20, 2025
A Guide to Toxicological Studies for GRAS Conclusion
Building your safety narrative for a GRAS notice begins with toxicological studies for GRAS conclusion, and this foundation is one of the
... Read more November 5, 2025
Time to Renew: FDA Drug Establishment and Listing Deadline Is Coming Up
If your company manufactures, repacks, relabels, or imports drugs for distribution in the U.S., it’s time to prepare for the
... Read more October 23, 2025
Your Guide to Achieving GRAS Approval for Enzymes
Getting GRAS status for an enzyme is one of the most important steps to ensure your ingredient is recognized as
... Read more October 12, 2025
FDA Declares Nicotinamide Mononucleotide Lawful in Dietary Supplements
After years of uncertainty and legal disputes, the U.S. Food and Drug Administration (FDA) declared on September 29, 2025, that
... Read more October 3, 2025
Preparing Instructions for Use for FDA Submission
Preparing Instructions for Use (IFUs) for FDA Submission for Medical Devices Preparing Instructions for Use for FDA submission can feel
... Read more September 26, 2025
FDA Self-Affirmed GRAS Pathway May Soon End
The self-affirmed GRAS pathway is closer than ever to being eliminated. On March 10, 2025, U.S. Health and Human Services
... Read more September 26, 2025
What You Need to Know About GMP Training
What is GMP training, and why does it matter? If your company makes, packages, labels, or imports health products, this
... Read more August 29, 2025
Senators Propose Bill To Eliminate Self-affirmed GRAS Loophole
A new bill introduced in the U.S. Senate could significantly alter how food ingredient safety is assessed, especially when it
... Read more July 24, 2025
How the SAFE Sunscreen Act Could Change FDA Compliance
Sunscreen compliance in the U.S. may be on the edge of its most significant update in over two decades. On
... Read more July 18, 2025
FDA Updates Food Labeling Compliance Program
The FDA Food Labeling Compliance Program has just been updated to help food manufacturers and importers meet U.S. labeling requirements
... Read more June 26, 2025
Comparing FDA 510(k) and PMA Pathways for Medical Devices
When preparing to launch a medical device in the U.S., one of the first and most important decisions you’ll make
... Read more June 23, 2025
How to Comply with the FDA’s NDI Notification Process
If you’re planning to introduce a new ingredient into your dietary supplement formula for the U.S. market, the FDA NDI
... Read more June 13, 2025
Pet Supplements or Veterinary Health Products? Understanding the Difference
If you are planning to market animal health products, the question of pet supplements or veterinary health products will come
... Read more June 11, 2025
FY 2025 OMUFA Fees Due June 2: What You Need to Know
The FDA has confirmed that FY 2025 OMUFA facility fees are due soon. If your business was registered as a
... Read more June 1, 2025
GRAS for Food vs. Feed: Understanding the Key Differences
When introducing a new substance into the market, one of the first questions you need to answer is whether it’s
... Read more May 31, 2025
Traditional Cosmetics vs. Cosmeceuticals: What’s the Difference?
Understanding the distinction between traditional cosmetics vs. cosmeceuticals is essential if you’re manufacturing or marketing skincare or beauty products in
... Read more May 28, 2025
Struggling With GRAS Compliance? Here’s What to Do
If you’re finding it difficult to navigate the GRAS process, you’re not alone. Whether you’re introducing a new food ingredient
... Read more May 15, 2025
FDA Approves Natural Food Colors for Safer Use
The FDA has officially approved three new food color additives derived from natural sources. These offer a safer alternative to
... Read more May 12, 2025
FDA Unannounced Inspections: What Foreign Manufacturers Need To Know
FDA unannounced inspections are no longer limited to U.S. facilities. The U.S. Food and Drug Administration (FDA) recently announced an
... Read more May 12, 2025
FDA Front-of-Package Labeling Deadline Extended
FDA Front-Of-Package Labeling Comment Period Extended The U.S. Food and Drug Administration has extended the comment period for its proposed
... Read more May 11, 2025
Navigating FDA and Health Canada Rules for Eczema Products
The eczema product market continues to grow as consumer demand increases, but that doesn’t mean you can jump in without
... Read more May 6, 2025
Comparing Cosmetic Compliance Standards: FDA and Health Canada
How FDA and Health Canada Regulate Cosmetics Differently Thinking about launching your cosmetic line in North America? Whether you’re a
... Read more May 1, 2025
FDA announces ESG NextGen launch for industry submissions
FDA ESG NextGen is now officially live. If your company needs to submit regulatory documents to the FDA, you’ll now
... Read more April 17, 2025
Food and Supplement Labeling: Canada vs US Requirements
If you’re trying to bring a food or supplement product to both the Canadian and US markets, you’ve probably already
... Read more March 31, 2025
Your Guide to Submitting a Medical Device to the FDA Without Errors
Submitting a medical device to the FDA can feel like navigating a maze. Even the most seasoned teams can overlook
... Read more March 18, 2025
Why Are FDA Food Contact Notifications No Longer Effective?
Have you heard about the recent updates to FDA Food Contact Notifications (FCN)? The FDA has determined that several FCN
... Read more January 6, 2025
FDA Updates Yogurt Standard: Key Changes for Manufacturers
Attention all yogurt makers, big and small! The U.S. Food and Drug Administration (FDA) has finalized changes to the standard
... Read more January 2, 2024
Choosing Between GRAS Notice and Self-Affirmed GRAS
If you’re introducing a new ingredient or additive into food products, understanding the GRAS Notice vs. Self-Affirmed GRAS pathways is
... Read more October 31, 2023
A Clear Guide to FDA 510(k) Submission Requirements
Introduction In the world of medical devices, ensuring patient safety and efficacy is paramount. The 510(k) submission process is a
... Read more September 28, 2023
Why is it crucial to avoid FDA Warning Letters for dietary supplements and health products?
As a business owner operating in dietary supplements and health products, you are undoubtedly aware of the ever-evolving regulatory
... Read more September 27, 2023
Everything businesses should know about submitting a 30-Day Pre-Market Notification and Structure-Function Claims
https://youtu.be/MlufAYFqQ1s In dietary supplements, navigating the intricate regulatory landscape is a challenging yet indispensable aspect of launching your product. Submitting
... Read more September 26, 2023
10 Steps to Sell Dietary Supplements in the U.S.
The dietary supplement industry in the U.S. is growing fast. More people are looking for vitamins, minerals, and other supplements
... Read more September 14, 2023
FDA Facility Registration & Renewals (FDA Medical Device, Food & Drugs)
Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
... Read more August 13, 2023
Everything to know about the GRAS Generally Recognized as Safe Database
Food manufacturers everywhere are willing to jump through hurdles to receive their GRAS Notifications and access to the generally recognized
... Read more August 9, 2023
Breaking Ground: How to open a drug testing facility FDA Facility Registration
Opening a drug testing facility can be a rewarding opportunity especially as demand for workplace and healthcare-related testing continues to
... Read more July 28, 2023
Decoding the Jargon: Medical Device approvals 510(K) V.S. PMA differences & process
Are you a medical professional or someone involved in the healthcare industry? If so, you’ve likely come across the
... Read more July 20, 2023
From customs clearance to delivery: How USA Import Services can benefit your supply chain
In today’s global economy, businesses increasingly use international trade to source materials and sell products. However, the complex regulations
... Read more July 18, 2023
Maximizing Results: How Clinical Trial Services support your research
As a researcher, you know that the success of your study depends on many factors, from the quality of your
... Read more July 14, 2023
FDA Cosmetics Regulations: A cosmetics business step-by-step guide
Introduction to Cosmetic Regulations by the FDA: Are you a cosmetics brand looking to navigate the complex world of FDA
... Read more July 6, 2023
NDI Classification Unlocked: The Ultimate Guide
When thinking about NDI Classification have you ever heard about the New Dietary Ingredient Notification in Ingredient Compliance? In today’s
... Read more June 30, 2023
Are Structure-Function Claims regulated? What should I know?
In marketing, the power of persuasive structure-function claims cannot be underestimated. Regarding consumer perception and product sales, structure-function claims have
... Read more June 29, 2023
The Role of FDA Agents in U.S. Compliance
In a world where the pharmaceutical industry is constantly evolving and new drugs are being introduced to the market every
... Read more June 28, 2023
The Ultimate Guide to Conducting Successful Clinical Trials
Introduction: Welcome to the ultimate guide to conducting a successful clinical trial, where we will delve into the best practices
... Read more June 23, 2023
FDA Toxicological Testing guidance for food additives Clinical Trials
The safety evaluation of direct food additives and color additives used in food will be evaluated in this blog post
... Read more June 21, 2023
The Importance of Amazon Seller Compliance: How to Avoid Penalties and Boost Sales
In today’s competitive marketplace, selling products on Amazon has become a lucrative opportunity for many entrepreneurs and businesses. However, navigating
... Read more June 21, 2023
Managing FDA Fees: Budgeting and Planning for Success
Are you a company in the healthcare or pharmaceutical industry looking to bring a new product to market? If so,
... Read more June 16, 2023
The Ultimate PMA Submissions Guide: The Importance of Proper Documentation
Proper documentation is essential in any business operation and is particularly crucial when it comes to PMA submissions. Preparing and
... Read more June 13, 2023
FDA guidance for EUA medical devices transition under PHE policies
The U.S. Food and Drug Administration (FDA) published two final guidelines on March 24, 2023, to help manufacturers of medical devices transition
... Read more June 13, 2023
Good Manufacturing Practices GMP for pharmaceutical companies
Introduction: When it comes to the pharmaceutical industry, there is no room for error. The production of pharmaceuticals requires strict
... Read more June 6, 2023
A Business Guide to Importing NMN Supplements Into Canada
As more and more people become health-conscious, the demand for supplements has skyrocketed. One of the most popular supplements on
... Read more June 2, 2023
How Manufacturers Can Register With the FDA
Are you running a business that deals with food, drugs, medical devices, cosmetics, or dietary supplements? If so, you must
... Read more May 25, 2023
The Role of FSVP Certification in Global Food Safety
In today’s global food supply chain, ensuring the safety and quality of food products is critical to protecting public health
... Read more May 25, 2023
The Importance of Food Safety Plans for Food Businesses
Are you considering getting your food safety certification? In today’s highly competitive food industry, ensuring your food products are safe
... Read more May 11, 2023
Why an FSVP Importer Is Essential for Food Safety
As our world becomes increasingly globalized, the importation of food has become a common practice. However, with growing concerns
... Read more May 3, 2023
How GRAS Notification Supports FDA Food Ingredient Approval
Introduction: In the dynamic realm of food innovation, ushering in new ingredients responsibly and securely is of paramount importance. This
... Read more April 25, 2023
Understanding FDA Furls and Their Impact on Medical Device Companies
https://youtu.be/yvnTszySkgg If you’re in the medical device manufacturing business, you’re likely familiar with the FDA’s regulations, including FDA Furls. However,
... Read more April 25, 2023
FTC puts nearly 700 companies on notice of product claim civil penalties
Introduction: On April 13th, the Federal Trade Commission sent letters to warn hundreds of marketers to refrain from misleading customers with product
... Read more April 21, 2023
How to get your Food Handlers License: Ultimate 5 step guide
https://youtu.be/NN8ZLynq6kE If you work in the food service industry, you may need to obtain food handlers license to ensure that
... Read more April 17, 2023
Everything you should know about FDA GRAS Status in 2023
https://youtu.be/wOKeuDAEfss Have you ever wondered what it means for a food or ingredient to be ‘Generally Regarded as Safe’ (GRAS)?
... Read more April 13, 2023
Software as Medical Devices (SaMD) Registration: What You Should Know
As technology continues to advance, the use of Software as Medical Devices (SaMD) is becoming more prevalent in the healthcare
... Read more April 13, 2023
BRC Certification Explained for Canadian Businesses
BRC certification is a globally recognized standard for food safety and quality management. In Canada, it has become increasingly important
... Read more April 12, 2023
Top 5 benefits of hiring an Importer of Record for International Trade
https://youtu.be/mWaBQzsa1_M Introduction Importing goods can be a complex process, especially when it comes to navigating customs regulations and compliance requirements.
... Read more April 11, 2023
What you should know about FDA Approvals for Drugs & Medical Devices
Introduction: FDA approvals can be a complex process, but understanding its important steps can give you insight into how drugs
... Read more March 27, 2023
FDA Registration Renewals: FDA Increases Facility Enforcement
As a business owner, keeping up with regulatory requirements is a top priority. One such requirement is the FDA’s renewal
... Read more March 22, 2023
What to Ask When Registering a Food Facility With the FDA
Quality Smart Solutions offers the best FDA Facility Renewal & Registration services in North America for Medical Devices, Food, and
... Read more March 21, 2023
What Companies Need to Understand About GRAS Ingredients
Introduction to GRAS: Understanding the regulations and safety risks associated with GRAS ingredients can be tricky, but it doesn’t have
... Read more March 16, 2023
Filing a Medical Device 510(k): Timing and Process Explained
Introduction: A 510(k) clearance is a process by which medical device manufacturers notify the FDA of their intent to market
... Read more February 21, 2023
5 Tips to Find the Best Medical Device Regulatory Consultant
Finding the right medical device regulatory consultant is one of the most important steps to ensure your product meets all
... Read more February 15, 2023
What Businesses Need to Know About FDA NAC Guidelines
Introduction: On August 1, 2022, the FDA announced the final guidance on FDA’s policy regarding products labeled as dietary supplements
... Read more February 8, 2023
FDA to tighten regulatory process around CBD food & supplements
Introduction: The FDA may have turned a blind eye to companies like Bio Steel in the past who’ve been selling
... Read more January 27, 2023
Making the Most of the FDA GRAS Database for Ingredient Safety
If you’re in the food or ingredient industry, you’ve likely heard about the FDA GRAS database. It’s a vital resource
... Read more January 18, 2023
A Practical Guide to Dietary Supplement Labelling Requirements
Introduction: The FDA offers an online dietary supplement labeling guide that provides labeling requirements for supplement manufacturers. The guide covers
... Read more January 11, 2023
FDA Prior Notice for Food Importers: Unlocking the FDA Guidelines
Introduction Prior notice is a requirement for all food manufactured, processed, packed, or held outside the United States that is
... Read more December 28, 2022
GRAS, NDI, ODI Food Additives & Generally Recognized as Safe GRAS
Introduction Food additives are chemicals added to food products to enhance flavor, texture, or color. Fortunately, there is a list
... Read more December 21, 2022
GRAS vs NDI: A Simple Guide to Ingredient Compliance
Understanding the differences between GRAS and NDI is essential for any company developing food ingredients or dietary supplements in the
... Read more December 6, 2022
5 FDA Warning Letters: Food Manufacturers of CBD Food Products
Introduction On November 21, 2022, the Food and Drug Administration (FDA) Center for Food Safety and Applied Nutrition issued warning
... Read more November 30, 2022
Medical Device License (MDL MDEL SaMD) Under the Microscope
The Medical Device License is a legal document required to manufacture, sell, and distribute medical devices. The Medical Device Licence
... Read more November 15, 2022
FDA NAC Warning Letter: Targeting N-Acetyl Cysteine (NAC) Supplements
Background on FDA NAC Warning Letters: Navigating the FDA’s NAC system can be overwhelming. Understanding FDA warning letters is key
... Read more November 2, 2022
Inside Scoop FDA Medical Device User Fees (MDUFA) for 2023
The FDA or U.S. Food and Drug Administration recently announced the Fiscal Year Medical Device User Fee (MDUFA) amendments. The
... Read more November 1, 2022
GRAS Consultants: NDIN or FDA GRAS Certification?
Say you have a new ingredient and are ready to enter the US food market. To ensure this ingredient is
... Read more October 28, 2022
5 Key Reasons Why Drug Identification Numbers Matter
Overview Manufacturers of prescription and non-prescription drugs are required to obtain a Drug Identification Number (DIN) before the drug product
... Read more August 10, 2022
Are Toxic Substances Hiding in Your Cosmetics?
What is a cosmetic? Under Section 2 of the Food and Drugs Act, a cosmetic is defined as “any substance
... Read more May 25, 2022
EUA FDA Transition Plan for Medical Devices in 2022
In response to the COVID-19 public health emergency, FDA issued a declaration regarding the appropriateness of utilizing emergency use authorizations
... Read more April 29, 2022
Top 10 Fruitful Medical Device Development Principles
Regulatory agencies across the globe, including the U.S. Food and Drug Administration (FDA), Health Canada, and the United Kingdom’s Medicines
... Read more February 9, 2022
FDA Qualified Health Claim for Magnesium 2022
The U.S. Food and Drug Administration (FDA) has communicated via Letter of Enforcement Discretion that it will not oppose or
... Read more February 3, 2022