So, you have an innovative product and a great business plan. The only thing standing between your warehouse and the U.S. market? A major regulatory hurdle called the Premarket Tobacco Product Application (PMTA). This is the FDA’s official process for showing your product meets a crucial public health standard. Your pmta application needs to be a complete scientific story, presenting solid evidence on everything from ingredients and health risks to your manufacturing methods. Getting your pmta approved is the only way to legally sell your product, making it a critical focus for any business in this space.
Key Takeaways
- Your Application Rests on Scientific Proof: The FDA requires a comprehensive, evidence-based case showing your product meets the “appropriate for the protection of public health” standard. This involves detailed studies on your product’s chemistry, manufacturing controls, and its potential effects on both users and the general population.
- Treat the PMTA as a Strategic Business Project: The entire process, from data collection to final review, can take years and demands significant resources. A successful application requires realistic timelines, strategic resource allocation, and knowing when to bring in regulatory experts to fill knowledge gaps.
- Compliance is an Ongoing Commitment, Not a Finish Line: A marketing granted order is the beginning of your long-term responsibilities. You must maintain the authorization through meticulous record-keeping, strict adherence to quality control protocols, and proactive monitoring of regulatory updates.
The PMTA Process Explained
If you’re looking to bring a new tobacco product to the U.S. market, the Premarket Tobacco Product Application (PMTA) process is your pathway to getting it there legally. Think of it as the FDA’s comprehensive review system, designed to evaluate whether your product is appropriate for protecting public health before it can be marketed or sold. This isn’t a simple form to fill out; it’s a detailed submission that requires substantial scientific evidence, a deep understanding of your product’s components and manufacturing processes, and a clear picture of its potential impact on consumers and non-consumers alike.
The PMTA process is rigorous because the FDA’s goal is to balance the potential for new products to help adult smokers move away from combustible cigarettes against the risk of attracting new users, particularly young people. Successfully completing a PMTA results in a marketing granted order, which is the official authorization you need to sell your product. The entire journey, from initial planning to final submission and review, demands careful attention to detail and a strategic approach. Understanding each step is the first move toward a successful application.
What is a Premarket Tobacco Application (PMTA)?
At its core, a Premarket Tobacco Product Application (PMTA) is the formal submission you send to the FDA to demonstrate that your new tobacco product meets their public health standards. It’s a comprehensive scientific dossier that presents evidence about your product’s ingredients, health risks, and manufacturing methods.
The ultimate goal of submitting a PMTA is to receive a marketing granted order from the FDA. This order confirms that the agency has reviewed your data and agrees that allowing your product on the market is appropriate for the protection of public health. Without this authorization, you cannot legally sell or distribute your new tobacco product in the United States. It’s the essential green light for market entry.
Other Meanings of PMTA (Just to Be Clear)
Before we go any further, let’s make sure we’re all on the same page. In the world of FDA regulations, PMTA stands for one thing: Premarket Tobacco Product Application. According to the official definition, a PMTA is “a special request that companies must send to the U.S. Food and Drug Administration (FDA). The FDA must review and approve this application before any new tobacco product can be legally sold in the United States.” This is the specific process we’re focused on here. It’s the required pathway for getting products like e-cigarettes, vape pens, and other modern tobacco innovations onto the market.
A Brief History of the PMTA Requirement
The PMTA requirement didn’t always apply to the wide range of products it covers today. For years, the FDA’s authority was limited primarily to traditional cigarettes. That all changed with a major regulatory shift. As new products entered the market, the agency expanded its oversight to ensure they were also being evaluated for their public health impact. This was a pivotal moment for the industry, fundamentally changing the requirements for market entry for a whole new category of businesses and innovators who were previously operating in a less regulated space.
In May 2016, the FDA made a rule that gave it power to regulate more tobacco products, including e-cigarettes, cigars, and vape pens. This rule also allows the FDA to stop companies from making claims that their products are less harmful if they don’t have proof. This expansion of authority is what made the PMTA a critical process for the modern tobacco industry, setting a new standard for scientific evidence and accountability before a product could reach consumers.
The 2016 “Deeming” Rule
The specific regulation that brought these changes into effect is often called the “Deeming” Rule. The name comes from the fact that the FDA officially “deemed” products like e-cigarettes and cigars to be tobacco products under its regulatory authority. The rule expanded its authority to include all tobacco products, not just traditional cigarettes. This means that any new tobacco product introduced to the market must undergo the PMTA process to ensure it meets public health standards. This single action reshaped the entire industry, placing a significant compliance burden on manufacturers who now had to provide extensive scientific data to keep their products on the market or introduce new ones.
Key Deadlines and Milestones
The FDA didn’t implement these new requirements overnight. The agency established a series of timelines to give manufacturers time to prepare their submissions. For the PMTA pathway, the FDA set different timelines for companies to follow, depending on the type of application. For the Premarket Tobacco Application (PMTA), companies had the longest time, a total of 36 months, with a final deadline of August 8, 2018, for some products, while a court order later established a September 9, 2020, deadline for many others. These dates became critical milestones, forcing companies to quickly gather data and prepare complex scientific applications to meet the cutoff and remain on the market pending FDA review.
Does Your Product Need a PMTA?
The PMTA requirement applies to any “new tobacco product.” The FDA defines a new tobacco product as one that was not commercially marketed in the U.S. as of February 15, 2007. This also includes any existing product that was modified in any way after that date. A modification can be anything from changing the ingredients or flavor profile to altering the design or components of a device, like an e-cigarette.
This means the PMTA rule covers a vast range of products, including most e-cigarettes, vaping devices, e-liquids, and other modern nicotine products. If you’re introducing a new item or even just tweaking an existing one, it’s almost certain you’ll need to go through the PMTA process to get it on the market.
Are There Alternatives? The Substantial Equivalence (SE) Pathway
If the PMTA process feels overwhelming, you might be wondering if there’s another way. For certain products, there is: the Substantial Equivalence (SE) pathway. This route allows you to show that your new tobacco product is “substantially equivalent” to a “predicate product”—a specific product that was on the market in the U.S. as of February 15, 2007. Your goal is to prove that your product either has the same characteristics as the predicate or that any differences don’t raise new public health concerns. While it can be a more streamlined route, it’s not a simple loophole.
To use this pathway, you must submit a Substantial Equivalence Report to the FDA. This report is a detailed, side-by-side comparison of your product and its predicate, backed by scientific data. The FDA needs compelling evidence that your product is not more harmful than the one it’s being compared to. While the SE pathway might require less extensive new health studies than a PMTA, it still demands a robust, evidence-based argument to successfully obtain a marketing order.
What Are the FDA’s Public Health Goals?
The central question the FDA seeks to answer through a PMTA is whether your product is “appropriate for the protection of public health.” This standard requires you to provide scientific data showing how your product will affect the population as a whole. The FDA weighs the potential benefits against the potential risks.
For example, you’ll need to present evidence on whether your product could help adult smokers transition away from more harmful combustible cigarettes. At the same time, you must show the likelihood—or unlikelihood—of non-smokers, especially youth, starting to use your product. It’s a careful balancing act, and your application must provide robust scientific studies and analyses to make a convincing case that the public health benefits outweigh the risks.
Recent PMTA Changes You Should Know
The regulatory landscape for tobacco products is always evolving, so staying informed is critical. A significant development was the FDA’s final rule on PMTAs, which established clearer requirements for the content, format, and review of these applications. This rule provides a more detailed roadmap for what applicants need to include, from product chemistry and manufacturing information to human health impact studies.
While this adds a layer of specificity to an already complex process, it also helps remove some of the guesswork. By following these established guidelines, you can structure your submission in a way that aligns with the FDA’s expectations. Keeping up with these kinds of regulatory updates ensures your application is current, complete, and ready for a thorough review.
What Goes Into a Winning PMTA Application?
Think of your PMTA submission as the complete biography of your tobacco product. It’s a detailed, evidence-based story that you present to the FDA, demonstrating why your product is appropriate for the protection of public health. A disorganized or incomplete application is one of the quickest ways to face delays or rejection, so getting the details right from the start is essential. For the FDA to even begin a substantive review, your application must contain all the required information.
Your submission needs to cover everything from the product’s chemical makeup to its potential impact on the environment. It’s a comprehensive package that includes scientific studies, detailed manufacturing plans, and strategies for monitoring the product long after it hits the shelves. Each piece of the puzzle gives the FDA a clearer picture of your product and its place in the market. We’ll walk through the five core components you absolutely must include to build a strong and compliant application.
How to Gather the Right Scientific Evidence
This is the heart of your PMTA. The FDA needs to see robust scientific data to support your claim that the product is appropriate for the protection of public health. This isn’t the place for assumptions; it requires extensive research and analysis. Your application should include a variety of studies, such as toxicological analyses to understand the product’s chemical risks, as well as clinical and behavioral studies that show how people are likely to use the product. The FDA’s guidance on Premarket Tobacco Product Applications details the kind of scientific investigation required to meet this critical standard. Your goal is to provide a full scientific picture of your product’s potential impact on both users and non-users.
Examples of Evidence from Approved Products
It helps to look at what has actually worked in the past. Examining products that have successfully received a marketing granted order gives you a clearer picture of what the FDA considers compelling evidence. The agency’s decisions always come back to that core standard: whether a product is “appropriate for the protection of public health.” This means your evidence must convincingly show that the potential benefits, like helping adult smokers switch from combustible cigarettes, outweigh the risks, such as the possibility of attracting young people or non-smokers. It’s a high bar to clear, and the FDA expects a thorough, data-driven case.
For instance, the very first PMTA approval was for eight “snus” smokeless tobacco products from Swedish Match. This set the precedent for the level of detail required. More recently, the FDA has issued marketing granted orders for several heated tobacco products. In each of these cases, the applicants provided extensive data from toxicological, clinical, and behavioral studies. They didn’t just describe their products; they demonstrated their potential impact on public health with hard numbers and scientific analysis. These examples show that a successful application is built on a foundation of comprehensive, well-organized scientific proof.
How to Detail Your Product and Manufacturing
The FDA needs to know exactly what your product is and how you make it. Your application must include a complete description of the product’s design, components, ingredients, additives, and materials. You should also provide a detailed narrative of the manufacturing process from start to finish. This includes where you source your materials, the methods you use for production, and the facilities involved. This level of detail allows the FDA to assess potential health risks and ensures that you can consistently produce the exact same product that was evaluated. Demonstrating this control is fundamental to meeting the FDA’s public health standards.
How to Complete the Environmental Impact Assessment
Many applicants overlook this step, but it’s a mandatory part of the PMTA process. Under the National Environmental Policy Act (NEPA), the FDA must consider the environmental consequences of authorizing a new product. You’ll need to prepare an Environmental Assessment (EA) that evaluates the potential impact of your product’s use and disposal on the environment. This includes everything from the raw materials used to the waste generated by consumers. If the FDA determines your product won’t have a significant impact, they will issue a Finding of No Significant Impact (FONSI). In some cases, your product might qualify for a categorical exclusion, but it’s wise to be prepared for a full assessment.
How to Document Your Quality Control
How can the FDA be sure that the product you sell tomorrow will be the same as the one you submitted for review today? The answer is a well-documented quality control system. Your PMTA must outline the quality control measures you have in place for every stage of production. This includes testing raw materials, monitoring the manufacturing line, and conducting final inspections on the finished product. Providing clear documentation of your protocols shows the FDA that you are committed to consistency and can reliably produce a product that meets all specifications. This builds confidence that your product will remain stable and safe for consumers.
Creating Your Post-Market Surveillance Plan
Receiving marketing authorization isn’t the end of your responsibilities. Your PMTA submission must also include a plan for post-market surveillance. This means you need to outline how you will monitor your product once it’s available to consumers. The plan should detail how you’ll track sales data, monitor user behavior, and collect information on any adverse health effects. Even after a product is approved, companies must keep records and report to the FDA. This ongoing oversight helps ensure the product continues to meet public health standards long after its initial approval.
Common PMTA Hurdles (And How to Clear Them)
The Premarket Tobacco Application (PMTA) process is notoriously complex, and it’s easy to feel overwhelmed by the requirements. Many companies, regardless of their size, run into similar challenges along the way. The good news is that these hurdles are not insurmountable. With careful planning and a clear strategy, you can successfully prepare a strong application that meets the FDA’s rigorous standards.
Think of the PMTA process as a marathon, not a sprint. It demands a significant investment of time, resources, and specialized knowledge. The most common stumbling blocks include underestimating the resources needed, failing to gather sufficient scientific data, creating an unrealistic timeline, and submitting poorly organized documentation. Getting ahead of these issues is key. By understanding where others have struggled, you can build a plan that anticipates challenges and keeps your submission on track. This proactive approach not only strengthens your application but also helps manage internal stress and budget concerns. Let’s walk through some of the most frequent hurdles and discuss actionable steps you can take to overcome them, turning potential roadblocks into manageable milestones.
How to Budget Your Time and Money
Successfully preparing a PMTA requires a team with diverse skills. You’ll need expertise in toxicology, regulatory science, manufacturing processes, and even consumer behavior to build a comprehensive application. Assembling this multidisciplinary team is one of the first major hurdles. For many businesses, hiring full-time experts in every field isn’t feasible. Instead, focus on identifying your internal strengths and pinpointing the gaps. You can then fill those gaps with specialized consultants or contract research organizations. A well-managed budget that allocates funds for both internal staff and external experts will set you up for a much smoother process and prevent costly surprises down the road.
How to Meet the FDA’s Data Requirements
At its core, a PMTA is a scientific argument. You must prove to the FDA that your product is “appropriate for the protection of public health.” To do this, your application needs to be supported by extensive scientific data. The FDA’s guidance on Premarket Tobacco Product Applications details the kind of scientific investigation required to meet this critical standard. This often includes detailed chemical analyses, toxicology studies, and assessments of user behavior. Gathering this data is time-consuming and expensive, so it’s crucial to start early. Ensure your studies are designed to answer the specific questions the FDA will have and that they follow established scientific protocols.
How to Create a Realistic PMTA Timeline
A common mistake is underestimating how long the PMTA process takes. From initial product development and data collection to the final submission and FDA review, the entire journey can span several years. It’s essential to create a detailed and realistic timeline that accounts for every stage. Map out key milestones for your studies, documentation drafting, and quality control checks. Remember to build in buffer time for unexpected delays, such as needing to repeat a study or address questions from your research partners. The final PMTA rule also outlines procedures for how the FDA communicates with applicants, so your timeline should be flexible enough to accommodate these back-and-forth interactions.
Get Your Documentation Right
Your final PMTA submission will be a massive collection of documents, and how you organize it matters. A clear, well-structured application makes it easier for FDA reviewers to find the information they need, which can help streamline the review process. The FDA has provided extensive resources, including guidance documents and webinars, to help manufacturers prepare their applications. Take advantage of these materials. Follow the recommended format, use clear headings, and create a detailed table of contents. Every claim you make should be clearly linked to its supporting data. Meticulous organization demonstrates your company’s commitment to quality and compliance.
When to Seek Expert Consultation
Even with a dedicated internal team, the highly specific nature of the PMTA process can be challenging. Knowing when to bring in outside help is a sign of a smart business strategy. Regulatory consultants live and breathe these applications. They understand the nuances of the FDA’s expectations and can help you avoid common pitfalls that could lead to a Refuse to File (RTF) letter or a deficiency notice. An expert can provide critical regulatory support, review your scientific data, and ensure your final submission is polished and complete. Investing in expert consultation can save you significant time and money in the long run and greatly increase your chances of receiving marketing authorization.
What to Expect During the FDA Review
Submitting your Premarket Tobacco Application (PMTA) is a major milestone, but it’s also the start of a new, critical phase: the FDA review. This is where your application undergoes intense scrutiny by agency scientists and reviewers. Understanding what happens during this period can help you prepare for potential questions and respond effectively. The review process is a structured dialogue between your company and the FDA, and knowing the steps involved will help you manage the process with confidence. From the initial evaluation criteria to post-approval responsibilities, each stage is designed to ensure your product meets the necessary public health standards before it can be legally marketed.
How the FDA Evaluates Your Application
The FDA’s evaluation goes far beyond just your product’s chemical makeup. Reviewers take a comprehensive look at the potential impact on the entire population, not just the intended users. They assess both the positive and negative effects on public health. For example, they will analyze your data to determine if your product might help current tobacco users switch to a less harmful alternative. At the same time, they will scrutinize whether the product could appeal to non-users, particularly young people, and lead them to start using tobacco. This balanced approach is central to the FDA’s mission to protect public health.
The FDA’s Step-by-Step Review Process
Once you submit your application, the FDA follows a clear, multi-stage process to evaluate it. This isn’t a single review but a series of checkpoints designed to thoroughly assess your product. The FDA’s review process has several distinct phases, starting with an initial check for completeness and moving into a deep scientific evaluation. It begins with an acceptance review to ensure your application meets basic requirements, followed by a filing review to confirm it has enough substance for a detailed scientific assessment. If it passes these initial gates, it moves to the substantive review, where FDA scientists dig into your data. The process concludes with a final decision—either a marketing granted order or a marketing denial order—and is followed by ongoing postmarket responsibilities if your product is approved.
What Do the FDA’s Decisions Mean?
Ultimately, the FDA’s decision comes down to a single, critical question: Is marketing your product “appropriate for the protection of the public health?” To get a yes, your application must provide a robust scientific case that the benefits to the public outweigh the risks. This isn’t a simple box-checking exercise. It requires extensive data from clinical and nonclinical studies, manufacturing process details, and an analysis of user behavior. A marketing denial order means the FDA has determined you haven’t met this standard, while a marketing granted order signifies your product is cleared for sale under the conditions specified by the agency.
Marketing Granted vs. Marketing Denial Orders
After the FDA completes its review, your PMTA will receive one of two outcomes: a marketing granted order or a marketing denial order. A marketing granted order is the official authorization you need to legally sell your product in the U.S. It signifies that the FDA has determined, based on your scientific evidence, that your product is appropriate for the protection of public health. On the other hand, a marketing denial order (MDO) means your application did not provide a strong enough case. The FDA issues an MDO when the evidence fails to demonstrate that the potential benefits to public health outweigh the risks. Understanding the distinction is crucial, as the entire PMTA process is designed to gather the evidence needed to secure that final marketing authorization.
How to Communicate Effectively with the FDA
The FDA has a formal process for communication during the review period. You won’t be left guessing about the status of your application. The agency provides updates and may reach out with questions or requests for clarification. The final PMTA rule outlines these procedures, including how you can amend your application with new information or withdraw it if needed. It’s important to maintain a designated point of contact who can manage all correspondence professionally and promptly. Clear, timely communication is key to keeping the review process moving forward and addressing any agency concerns as they arise.
How to Address Application Deficiencies
It’s not uncommon to receive a “Deficiency letter” from the FDA during the review. This isn’t a rejection; it’s a request for more information. FDA scientists and, in some cases, the Tobacco Products Scientific Advisory Committee, conduct a deep dive into your submission. If they find gaps or need clarification on your data, they will issue this letter detailing exactly what is needed. Your job is to provide a complete and timely response that directly addresses their questions. A thorough, well-organized reply can resolve the deficiency and prevent significant delays in your application’s review.
How to Find Public Information on FDA Decisions
Staying on top of the FDA’s decisions is a crucial part of operating in the tobacco industry. The agency is transparent about which products have successfully completed the review process and received authorization to be sold. This public information is not just for consumers; it’s an invaluable resource for businesses like yours. By reviewing which products have received marketing orders, you can gain insights into the types of applications and scientific evidence the FDA finds compelling. This helps you stay informed about the competitive landscape and understand the current regulatory standards in practice. Knowing where to find this information is a key part of your strategic planning.
Using the Searchable Tobacco Products Database
The best place to start is the FDA’s Searchable Tobacco Products Database. This is an official, public-facing tool that lists all tobacco products that have received a marketing granted order. For a company to legally sell a new tobacco product, they must get this written authorization from the FDA, and this database is the public record of those decisions. When the agency grants an order, they often share key documents, like the approval letter and a summary of their decision, which provide a window into their evaluation process. You can access the database directly on the FDA’s website to see which products have met the public health standard and are legally on the market.
What Are the Post-Approval Requirements?
Receiving a marketing granted order is the goal, but it’s not the final step. FDA approval comes with ongoing responsibilities to ensure your product continues to meet public health standards. Companies must implement robust record-keeping systems and submit regular reports to the FDA. These postmarket surveillance activities are mandatory. They help the FDA monitor the product’s real-world impact and ensure it remains appropriate for the protection of public health long after it hits the market. Maintaining compliance is just as important as achieving it in the first place.
You’re Approved! How to Stay Compliant
Receiving a marketing granted order (MGO) from the FDA is a monumental achievement, but the work doesn’t stop there. Think of your PMTA approval not as the finish line, but as the start of a long-term relationship with the FDA. Maintaining compliance is an ongoing commitment that protects your product’s place on the market and, more importantly, upholds public health standards. The FDA continues to monitor approved products to ensure they remain safe and consistent with what was authorized. This means your post-market responsibilities are just as critical as your initial submission. From meticulous record-keeping to managing product changes, staying on top of your obligations is key to long-term success.
How to Set Up Your Record-Keeping System
Once your product is on the market, you need a robust system for keeping records. The FDA requires you to document and report on your product’s performance to ensure it continues to be safe for consumers. Your record-keeping system should be organized, accessible, and thorough, tracking everything from manufacturing batches and quality control tests to consumer complaints and any adverse event reports. This isn’t just about checking a box; it’s about creating a detailed history of your product that demonstrates ongoing compliance. A well-maintained system allows you to respond quickly to any FDA inquiries and shows that you are proactively monitoring your product’s impact.
Need to Change Your Product? What to Do Next
Thinking about tweaking your product’s formula, design, or even the manufacturing process? You need to proceed with caution. Any modification to an FDA-authorized product must be carefully evaluated to see if it requires notifying the agency. Depending on the significance of the change, you might need to submit a new Premarket Tobacco Product Application or a supplemental application. The final PMTA rule outlines the procedures for amending an application, so it’s crucial to understand what’s required before you act. Making unauthorized changes can put your marketing order at risk, so always consult the regulations or a compliance expert first.
How to Maintain Your Quality Control Protocols
Consistency is everything when it comes to a regulated product. The product you sell must be identical to the one the FDA approved in your PMTA. This means you have to strictly adhere to the quality control protocols you established in your application. Regular testing, consistent manufacturing practices, and thorough supplier vetting are non-negotiable. These protocols are your promise to the FDA and the public that every unit leaving your facility meets the same safety and quality standards. Any deviation could not only harm consumers but also trigger an FDA audit and jeopardize your authorization.
How to Stay on Top of Regulatory Changes
The regulatory environment is always evolving. New rules are published, and guidance documents are updated. It’s your responsibility to stay informed about any changes that could affect your product or your compliance obligations. You can do this by regularly checking the FDA’s website, subscribing to official newsletters, and participating in industry trade groups. Because these updates can be complex, many companies find it helpful to work with a regulatory consultant who can interpret the changes and advise on the best course of action. Staying current ensures you can adapt your processes proactively and avoid any compliance gaps.
How to Maintain Your Market Authorization
Your marketing authorization is conditional on your continued compliance. The FDA has the authority to withdraw its approval if it determines a product is no longer “appropriate for the protection of public health.” This can happen for several reasons, including a failure to submit required post-market reports, making unauthorized product changes, or if new scientific data reveals unforeseen risks. To protect your authorization, you must fulfill all your post-market requirements diligently. Think of it as an ongoing demonstration that your product continues to meet the high standards set by the FDA when it was first approved.
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Frequently Asked Questions
Why does the PMTA process take so long? The timeline feels long because the FDA’s review is incredibly thorough. They are tasked with protecting public health, which means their scientists must carefully analyze every piece of your submission. This includes reviewing extensive data from your scientific studies, assessing your manufacturing processes, and weighing the potential risks and benefits of your product for the entire population. The process also involves back-and-forth communication, where the agency may ask for clarification or additional data, which adds to the overall timeline.
Do I really need a new PMTA for a minor change to an existing product? Yes, in most cases, you do. The FDA defines a “new tobacco product” as any product that was modified after February 15, 2007. From a regulatory standpoint, even a seemingly minor change—like altering an ingredient, changing a component in a device, or updating the flavor profile—creates a new product. This is because any modification could potentially change the product’s health impact, requiring a fresh review to ensure it still meets the public health standard.
What’s the most common reason a PMTA submission gets delayed or rejected? The most significant hurdle is often a lack of sufficient scientific evidence to prove the product is appropriate for the protection of public health. Simply submitting data isn’t enough; the evidence must be robust and persuasive. Another common issue is poor organization. If reviewers can’t easily find the information they need, your application can be refused right at the start, before a full scientific review even begins.
Is it possible to handle the PMTA process entirely in-house? While it’s technically possible if you have a large, dedicated team of regulatory and scientific experts, it’s a huge undertaking. Most companies find that partnering with a regulatory consultant is a more practical approach. An experienced consultant has been through this process many times and can help you avoid common pitfalls, structure your submission correctly, and ensure your scientific studies are designed to meet the FDA’s expectations, which can save you a great deal of time and resources.
What happens if I don’t keep up with post-market reporting after my product is approved? Failing to meet your post-market obligations is a serious compliance issue. Your marketing granted order is conditional upon fulfilling these requirements, which include submitting regular reports and maintaining detailed records. If you don’t comply, the FDA can determine that your product is no longer appropriate for the protection of public health and has the authority to withdraw your marketing authorization, meaning you would no longer be able to legally sell the product.