Frequently Asked Questions
About FDA Atty
It depends on your situation and the violation of the legislation. At FDA Atty, we have experience working within the FDA landscape and can ensure we meet the strict timelines set out by the FDA.
At FDA Atty, you have direct access to Marc Sanchez, senior counsel. Marc is available to discuss your case and answer any questions you may have.
We have over a decade of experience working with FDA legislation in the food, dietary supplement, beverage, cosmetic, medical device, tobacco, and drug industries.
No. Our practice is limited to proceedings regarding the FDA. This unique focus enables us to have highly specialized knowledge of this area.
No, our practice helps clients from coast to coast and around the world. We connect with clients by phone, e-mail, WhatsApp, and Skype no matter where they are.
FDA Approval
FDA food contact formulation (FCF) notification guidance plays an important role in determining regulatory status of components of a Food Contact Material.
Many industry professionals may be surprised to learn the FDA regulates food packaging. Food packaging is considered an indirect food additive. Determining the regulatory status of your food contact material can be challenging in part because of the number of options to choose from. Those options include:
- Consulting 21 CFR 174-179 to see if the use of the component is an appropriately regulated indirect additive,OR
- Consulting
Food canning establishment regulations are unique among food registration regulations. The FDA requires companies that produce certain shelf-stable, aseptically-sealed low-acid canned or acidified foods to obtain a Food Canning Establishment (FCE) registration. In addition, manufacturers must file documentation with U.S. FDA for each process used in the production of foods subject to these requirements. These submissions are known as a “Process Filing” and each is assigned a unique “Submission Identifier” (SID). This three part system forms the basis for the food canning establishment regulations.
Failing to register either yourself as an importer or your foreign manufacturer could lead to fines and penalties from the US FDA. Registration also demonstrates to distributors, import brokers, and insurers your professionalism and understanding of the regulations.
Avoid U.S. FDA refusals and detentions when shipping canned, bottled, jarred, and other shelf-stable foods in the United States by ensuring your food canning establishment is properly registered and your scheduled processes are properly filed. Please contact our Charlotte or Washington D.C. offices for a complimentary consultation on
FDA Certificate of Origin offer US companies an opportunity to demonstrate FDA approval and/or compliance. Facilities exporting products from the United States to a foreign market are often asked to supply an export “certificate” for products regulated by U.S. FDA. An Export Certificate is a document prepared by U.S. FDA containing information about a product’s regulatory or marketing status.
Contact us today for assistance selecting and completing the correct form.
U.S. FDA currently offers the following types of Export Certificates:
FDA Dietary Supplement Claims
**Please contact our Washington D.C. office if you require an urgent FDA dietary supplement review. Urgent reviews can typically be completed in one business day.**
FDA dietary supplement label review is an important step to complete prior to entering the market. A proper FDA dietary supplement label review will not only identify the rote regulatory requirements, such as statement of identity on the PDP, but also identify claims that pose a risk of reclassification. Reclassification results in a product marketed as a dietary supplement reclassified as a new unapproved drug. This new unapproved drug cannot be on the market.
What is a Dietary Supplement
A FDA dietary supplement label review begins by looking at whether the product meets the dietary supplement definition. The definition for dietary supplements is narrow and only includes ingested products. The question also asks whether the ingredients used are pharmaceutical, GRAS, or require a New Dietary Ingredient submission. Overlooking ingredient classification can be a common mistake in FDA dietary supplement label reviews.
Claims and Intended Use
There are three types of claims made on dietary supplement labels. Those are nutrient content, health/qualified health, and structure function claims. Each type of claim carries a specific definition and requirements that must be followed. A FDA dietary supplement label review identifies those criteria and ensure the claims made comport with the regulations. Skipping this step can lead to a Warning Letter for unapproved claims.
Claims also play an important role in assessing intended use. The intended use is a short-hand for reclassification. The label must objectively demonstrate an intended use through claims, images, and indirect claims to supplement a consumer’s health. Commonly regulatory professionals state a dietary supplement cannot make a claim to “treat/mitigate/cure” a disease or condition. This is an inverse way of saying those claims lead to reclassification as an unapproved new drug. This is perhaps one of the most important parts of a FDA dietary supplement label review.
Label and Labeling
A FDA dietary supplement label review should focus on all aspects of labeling. A common misconception is that FDA authority only extends to the product packaging. This is not true. The FDA exercises authority over “labeling” which has been judicially defined as any material that accompanies the product. This broad definition brings websites, social media, videos, radio programs/ad, and SEO into the scope of a FDA dietary supplement label review. A reviewer should include this material in the advice given.
Please contact our Charlotte or Washington D.C. office for more information on a FDA dietary supplement label review.
At FDA Atty, you have direct access to Marc Sanchez, senior counsel. Marc is available to discuss your case and answer any questions you may have.
Absolutely. We can advise you on what language you can and cannot use on packaging and marketing, so you can make smart decisions for your business.
We have over a decade of experience working with FDA legislation in the food, dietary supplement, beverage, cosmetic, medical device, tobacco, and drug industries.
No. Our practice is limited to proceedings regarding the FDA. This unique focus enables us to have highly specialized knowledge of this area.
No, our practice helps clients from coast to coast and around the world. We connect with clients by phone, e-mail, WhatsApp, and Skype no matter where they are.
Guidance on Self-Affirming GRAS and GRAS Notifications
FDA GRAS Petition Consultants:
Review of Guidance and Regulatory Requirements
FDA infant formula approval and notification is an important and detail process that must be completed before sales begin. Infant formula is a unique area of food regulation. The FDA rightfully views infants as a vulnerable population who rely on the formula as the sole source of nutrition. Parents place a great deal of trust in the product. To maintain that trust the FDA subjects infant formula to additional steps prior to entering the market.
Typically conventional foods (non juice, seafood, or low-acid/acidified canned food (LACF) are simply subject to registration with the FDA. Importers and manufacturers of infant formula not only must register, but also submit a 90-day notification and verification of the formula. A summary of those steps and the timing is provided below.
FDA Medical Device Classification
Verify The FDA Will Not Refuse to Accept Your 510K
When preparing a medical device 510k submission there are a number of important steps. The FDA medical device RTA checklist (a/k/a refuse to accept checklist) can often be an overlooked among the many moving pieces. Among the time-pressure to complete and submit the 510k in order to enter the market it is important to pause to ensure a submission will not be refused. A refused submission will only add to the delays.
The FDA published a Guidance Document (The Guidance for Industry and Food and Drug Administration Staff: Refuse to Accept Policy for 510(k)s) that describes the criteria FDA uses in assessing whether a 510(k) submission meets a minimum threshold of acceptability and should be accepted for substantive review. This Guidance Document provides the FDA medical device RTA checklist for traditional, abbreviated, and special 510ks.
The FDA medical device RTA checklist is not only a tool for industry but a new part of the medical device review. Beginning in 2013 the FDA implemented an administrative review. According to the Guidance Document this review must occur within 15 days of receiving the submission and prior to the substantive review. In the administrative review the FDA medical device RTA checklist is completed by the reviewer to determine if the submission is ready for substantive review or should be refused.
The FDA medical device RTA is dense with detail. The traditional 510k RTA checklist for example fills nearly 25-pages. It covers the basic topics of the 201(h) medical device definition to documentation on software or other performance data. The detailed RTA checlist can lead to a staggering number of refusals. It is important to make the FDA medical device RTA checklist a familiar part of the 510k drafting process as early as possible and every employee involved in the device acquainted with its requirements.
Please contact our Charlotte or Washington D.C. office for a complimentary consultation on FDA medical device regulation, including the FDA medical device RTA checklist.
Overview
FDA Prior Notice Imports is a relatively new requirement. Since December 12, 2003, FDA prior notice must be provided for all food for humans and animals that is imported or offered for import into the United States (Title 21 Code of Federal Regulations (21 CFR), Part 1, Subpart I). This is
Medical Devices FAQs
FDA-regulated medical devices are products intended for medical purposes (Sec. 201(h)), such as diagnosing, preventing, or treating diseases or conditions. These devices must meet FDA safety and effectiveness standards, and their marketing requires approval or clearance based on risk classification.
The FDA regulates a wide range of medical devices, including diagnostic tools, surgical instruments, imaging devices, and implants. These devices are categorized into three classes (I, II, III), depending on their risk level and regulatory requirements.
Medical devices cannot be marketed or sold in the U.S. without FDA approval or clearance, unless they meet specific exemptions. For high-risk devices, pre-market approval (PMA) is required. Moderate-risk devices (Class II) may only require a 510(k) clearance.
No, you cannot legally sell medical devices in the U.S. without FDA approval or clearance. Selling unapproved devices violates FDA regulations, which could lead to fines, recalls, and other legal consequences.
FDA approval means that a medical device has undergone rigorous review to ensure it is safe and effective for its intended use. For high-risk devices, this approval involves pre-market approval (PMA) to demonstrate compliance with FDA standards.
Medical devices are classified into three categories based on their risk level: Class I (low risk), Class II (moderate risk), and Class III (high risk). The classification determines the regulatory pathway and requirements for approval or clearance.
The 21 CFR (Code of Federal Regulations) part for medical devices is Part 820, which sets the FDA's Quality System Regulations (QSR) for manufacturing practices. It outlines the design, testing, production, and post-market surveillance requirements to ensure device safety and efficacy.
21 CFR Part 820 provides the regulatory framework for the design, production, and quality control of medical devices. It establishes mandatory requirements for quality systems, including design controls, production controls, and corrective and preventive actions to ensure device safety and effectiveness.
21 CFR 807 governs the pre-market notification (510(k)) process for medical devices. It outlines the requirements for manufacturers to submit documentation to the FDA to demonstrate that a device is safe and effective before marketing.
Manufacturers, reprocessors, and repackagers of medical devices must register their establishments with the FDA. They are also required to list their devices with the FDA to ensure compliance with regulatory requirements for marketing and sales.
The Medical Device Reporting (MDR) regulations require manufacturers, importers, and device users to report adverse events and device-related problems to the FDA. These regulations ensure timely action to protect public health from unsafe medical devices.
The 510(k) submission is for devices that are substantially equivalent to existing devices. PMA (Pre-market Approval) is required for high-risk devices, while De Novo submissions are used for novel devices without existing counterparts. Each pathway ensures safety and effectiveness.
A 510(k) submission is required for devices classified as moderate risk (Class II) under FDA guidelines. for devices classified as moderate risk (Class II) under FDA guidelines.
The approval process for a medical device can take several months to a few years, depending on the device's complexity and classification. A 510(k) clearance typically takes about 3 to 6 months, while PMA approval may take 1-3 years. This timing does not account for the data collection needed for a submission.
A U.S. Agent acts as a liaison between foreign medical device manufacturers and the FDA. They are required for non-U.S. manufacturers to facilitate compliance, communications, and FDA-related submissions for devices marketed in the U.S.
FDA labeling requirements ensure that medical devices provide accurate and clear information regarding their intended use, risks, and instructions for safe use. Labels must comply with FDA standards to protect consumers and ensure regulatory compliance.
During an FDA inspection, the agency reviews a company’s quality systems, manufacturing practices, and device records to ensure compliance with FDA regulations. Inspectors assess the company’s adherence to 21 CFR Part 820, among other requirements.
Form 483 is issued when FDA inspectors identify non-compliance with regulations during an inspection. A medical device company must respond within 15 days, outlining corrective actions taken to address the issues and bring operations into compliance.
ISO 13485 is not mandatory but is widely used to demonstrate compliance with FDA regulations. It provides a framework for quality management systems in the medical device industry and helps manufacturers meet FDA requirements for design and production.
ISO 13485 and 21 CFR 820 both establish quality management systems for medical devices, but ISO 13485 is an international standard, while 21 CFR 820 is specific to the FDA. ISO 13485 is often used to support compliance with FDA regulations.
FDA QSR (Quality System Regulations) and ISO 13485 both focus on quality management in medical device manufacturing. QSR is mandatory for FDA-regulated companies, while ISO 13485 is a voluntary standard that supports regulatory compliance and provides a broader international framework.
The FDA has not formally adopted ISO 13485 as the standard for U.S. medical device manufacturers. However, ISO 13485 is often recognized as a valuable tool for ensuring compliance with FDA regulations, and its use is encouraged for global manufacturers.
FDA Q&A
It depends on your situation and the violation of the legislation. At FDA Atty, we have experience working within the FDA landscape and can ensure we meet the strict timelines set out by the FDA.
Sharing FDA Medical Device Approval
There is a Limited Allowance
Ingredient and Label Compliance Begins with Supplement Definition
FDA dietary supplement definition is the first step in assessing whether a product qualifies for regulation under the supplement provisions of the Food Drug and Cosmetic Act (FD&C). If the product cannot be defined as a dietary supplement than it is often reclassified by the FDA as a drug and subject to harsh penalties for failing to follow the drug regulations.
FDA dietary supplement definition carries two two primary constraints. The first focuses on the ingredients or what the product is made from. The second focuses on how the product is used. The dietary supplement definition is limited to ingredients that are not active pharmaceutical ingredients. There are other constraints such as determining whether the ingredient is GRAS or new and requires a New Dietary Ingredient application. The more common focus is on intended use. This concept focuses on labeling and how the consumer is expected to use the product. This use can focus on whether the product is oral, topical, injected or inhaled. If not oral, then the intended use is for the consumer to use the product as a drug. The use can also center on whether the product is for a medical purpose. This is commonly referred to by the short-hand “cures/mitigates/treats.” The FDA views dietary supplements narrowly as serving to supplement dietary ingredients missing from the diet. There is no accommodation for traditional uses or natural remedies. Understanding these definitions is important when reviewing labels.
FDA Regulations – Resource Center
The FDA regulations are as vast as they are complex. The Agency provides oversight for food, bottled water, juice, seafood, canned food, dietary supplements, tobacco products, drugs, devices, cosmetics, and animal products. In each area is a unique set of FDA regulations. Our collection of blog posts and summaries of FDA regulations are provided below. The FDA regulations in the resource center our grouped by product. Click the links below to visit the FDA regulations related to each product category.
FDA Enforcement
Absolutely. We can advise you on what language you can and cannot use on packaging and marketing, so you can make smart decisions for your business.
Getting any letter from the FDA can be stressful, but you have options. The first step is to engage an attorney that can help you put a structure in place to extend your deadline. Contact us to book a free 20-minute consultation so you can start the process.
Center for Tobacco Issues More Warning Letters than Any Other Center
Tobacco retailer warning letters are surprisingly active area of FDA regulation. In 2014 the FDA issued 8,220 tobacco retailer warning letters. This surpassed the 470 warning letters issued to device, drug, food, supplement, pet, and cosmetic companies combined. An active area of regulation requires careful attention.
Tobacco retailer warning letters also require a strategic response. The volume of tobacco retailer warning letters indicates a strict application of the Federal Food, Drug, and Cosmetic Act, as amended by the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and its regulations in effect, such as the Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents, found at Title 21 of the Code of Federal Regulations, Part 1140 (21 C.F.R. Part 1140).
Tobacco Retailer Warning Letter Can Result in Civil Money Penalties
The FDA’s Center for Tobacco Products (CTP), generally sends Warning Letters to retailers the first time a tobacco compliance check inspection reveals a violation of the federal tobacco laws and regulations that FDA enforces. Failure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may lead to enforcement actions, including Civil Money Penalties. This effort to avoid CMP underscores the need for the right response.
The right response is:
Timely – only 15 days for initial response;
Professional – avoid anger, Constitutional issues like free speech, or accusations about the legality of the tobacco retailer warning letter;
Detailed – the reply should address every concern raised and cite appropriately to the regulations;
Corrective – part of the detail should be a comprehensive plan of action to correct violations.
Following the above outline provides a strong basis to respond to a tobacco retailer warning letter. Please call or Washington D.C. or Charlotte offices if you would like a complimentary consultation for your tobacco retailer warning letter.
It’s important to understand that there are 3 different types of inspections, and the expectations are somewhat different.
- Pre-Approval Inspections (PAI):
Form FDA 483s are public information and thus available through the FDA
FDA Regulations – Resource Center
The FDA regulations are as vast as they are complex. The Agency provides oversight for food, bottled water, juice, seafood, canned food, dietary supplements, tobacco products, drugs, devices, cosmetics, and animal products. In each area is a unique set of FDA regulations. Our collection of blog posts and summaries of FDA regulations are provided below. The FDA regulations in the resource center our grouped by product. Click the links below to visit the FDA regulations related to each product category.
FDA Warning Letter Requirements:
FDA Warning Letter requirements detail the purpose of the Warning Letter. The FDA considers a warning letter simply a notification of serious violations. This notification acts as a placeholder should the FDA decide at any time to pursue remedies for the identified violations. Civil remedies include recalls, seizures, injunctions, and more. Criminal penalties typically follow several unresolved warning letters.
FDA Warning Letter requirements also distinguish how it differs from the Form 483 issued following an inspection. The primary difference between the Form 483 and the Warning Letter is the significance of the Warning Letters. Warning Letters typically represent an escalation of the regulatory violations. Form 483s are issued by inspectors and not reviewed by superiors prior to release. This means only a handful of potential violations are captured in a Form 483. The Warning Letter, however, is issued by a District or Center Director and often reviewed by the Office of Legal Counsel prior to release. Thus, Warning Letters can cover a broader range of topics and reflect more significant violations.
FDA Warning Letter Requirements – Who and When?
The FDA Warning Letter will identify the time to respond – only 15 days – and who to submit the response to. This is the most basic and universal feature of a FDA Warning Letter.
Remember the FDA Warning Letter will appear on the Agency’s public database and be part of the bi-weekly Warning Letter e-mail newsletter.
FDA Form 483 Guidance
FDA Form 483 Guidance provides an overview of the Form 483 Inspectional Observations following a facility inspection. In this part the Form 483 is outlined to provide the reader a better understanding of what role the Form 483 serves for
An FDA enforcement action is a regulatory measure the U.S. Food and Drug Administration takes to ensure companies comply with laws governing food, drugs, medical devices, and other products.
Common FDA enforcement actions include warning letters, recalls, import holds, import alerts, injunctions, seizures, and civil or criminal penalties. These aim to address and correct violations of FDA regulations.
The FDA typically takes action based on inspection findings, product testing, adverse event reports, or complaints indicating violations of safety or regulatory standards.
A warning letter is a notice of regulatory violations requiring correction. A recall is a removal or correction of marketed products that violate FDA laws.
Yes. Companies can appeal certain FDA actions through formal dispute resolution processes, request hearings, or challenge actions in court, depending on the situation.
Consequences can include fines, product seizures, recalls, loss of market access, reputational damage, or even criminal charges in severe cases of noncompliance.
An FDA seizure involves court action to remove non-compliant products from commerce. It can lead to legal proceedings, fines, and reputational damage for the company.
Companies should understand the regulations specific to its products, e.g. drugs, devices, etc., maintain robust quality systems, conduct regular audits, train staff, follow GMPs, claims compliance, and promptly correct issues identified during FDA inspections or internal reviews.
FDA inspections assess compliance with regulations. If serious violations are found, inspections can lead to warning letters, recalls, or other enforcement actions.
Yes. Most enforcement actions, including warning letters, recalls, and consent decrees, are published on the FDA website to inform the public and industry.
The company must investigate, develop a recall strategy, notify affected parties, correct the issue, and report progress to the FDA until the matter is resolved.
Resources include FDA guidance documents, industry associations, regulatory consultants, and legal counsel experienced in FDA matters to help navigate enforcement issues.
An FDA enforcement attorney can advise on response strategies, communicate with the FDA, protect legal interests, and help achieve compliance while minimizing legal risks.