What is Substantial Equivalence. A 510(k) requires demonstration of substantial equivalence to another legally U.S. marketed device. Substantial equivalence means that the new device is at least as safe and effective as the predicate.
What is a substantial equivalence tobacco product?
A substantially equivalent tobacco product is one that has been found by FDA to have either the same characteristics as a predicate product or has different characteristics than the predicate tobacco product but the Substantial Equivalence Report demonstrates that the new product does not raise different questions of public health.
What is a substantial equivalence report?
A Substantial Equivalence (SE) Report can be submitted by any manufacturer for any new tobacco product seeking an FDA substantially equivalent order, under section 905 (j) of the Federal Food, Drug, and Cosmetic (FD&C) Act.
What is an exemption from substantial equivalence?
An EX REQ can be submitted by the original manufacturer for any new tobacco product seeking an FDA exemption order, under section 905 (j) (3) of the Federal Food, Drug, and Cosmetic (FD&C) Act. A new tobacco product may be considered for an exemption from Substantial Equivalence (SE) if FDA determines that:
What is substantially equivalent to a predicate?
Substantial equivalence means that the new device is as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; and has the same intended use as the predicate; and
What is substantial equivalence FDA?
Substantial equivalence means that the new device is as safe and effective as the predicate. A device is substantially equivalent if, in comparison to a predicate it: has the same intended use as the predicate; and. has the same technological characteristics as the predicate; or.
What do you mean by substantial equivalence?
In food safety, the concept of substantial equivalence holds that the safety of a new food, particularly one that has been genetically modified (GM), may be assessed by comparing it with a similar traditional food that has proven safe in normal use over time.
How is substantial equivalence determined?
To demonstrate substantial equivalence, manufacturers must show that the new device performs the same function(s) as the predicate device, is intended for the same use as the predicate device, and that any differences between the two devices do not raise any new safety or efficacy concerns.
What are the two pillars of substantial equivalence?
The two pillars of substantial equivalence are ‘intended use’ and ‘technological characteristics’.
Which part of convention can be covered by substantial equivalence?
The notion of substantial equivalence was also included in article 2(a) of the Merchant Shipping (Minimum Standards) Convention, 1976 (No. 147 ) to reflect the idea that deviations from the terms of the Convention could be admitted as long as the general level of protection remained the same.
What is the difference between PMA and 510 K?
A PMA is more in-depth than a 510k – it is used to prove that a new device is safe and effective for the end user and typically requires clinical trials with human participants along with laboratory testing.
What is substantial equivalence GMO?
56: Substantial Equivalence of GM and Non-GM Crops In other words, substantial equivalence means that a new product such as a GM crop must be the same as the non-GM crop except for the traits that were enhanced, added, or removed through genetic engineering.
What is a 513g FDA?
Section 513(g) of the Federal Food, Drug, and Cosmetic Act provides a means for device manufacturers to obtain information about the Food and Drug Administration’s views regarding the classification of a device. According to the legislation, a company can submit a written request to the secretary.
What is a reference device 510 K?
A Premarket Notification [510(k)] is a premarketing submission made to FDA to demonstrate that the device to be marketed is safe and effective by proving substantial equivalence (SE) to a legally marketed device (predicate device) that is not subject to Premarket Approval (PMA).
What does FDA 510k clearance mean?
Overview. Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification – also called PMN or 510(k).
What is the difference between FDA clearance and approval?
This is because the distinction between approved and cleared is significant: While FDA-approved means that the FDA has decided that the benefits of the product outweigh the known risks and manufacturers have to submit a pre-market approval application–as well as clinical testing results–in order to get approved, FDA- …
What is IDE FDA?
An investigational device exemption (IDE) allows the investigational device to be used in a clinical study in order to collect safety and effectiveness data. Clinical studies are most often conducted to support a PMA. Only a small percentage of 510(k)s require clinical data to support the application.
What is a substantial equivalency fair housing law?
Substantial equivalency certification is granted if the Department determines that a state or local agency enforces a law that is substantially equivalent to the Fair Housing Act with regard to substantive rights, procedures, remedies, and the availability of judicial review.
How do you use equivalence in a sentence?
1. The math teacher taught the students to check the equivalence of the fractions, showing them that ½ is equal to 5/10. 2. Amelia’s parents measured her room and her brother’s to prove their equivalence and stop the arguments about whose is bigger.
What is equivalence in math?
Equivalent means equal in value, function, or meaning. In math, equivalent numbers are numbers that are written differently but represent the same amount.
What is a substantial equivalent report?
A substantially equivalent tobacco product is one that has been found by FDA to have either the same characteristics as a predicate product or has different characteristics than the predicate tobacco product but the Substantial Equivalence Report demonstrates that the new product does not raise different questions of public health. A predicate tobacco product is one that was commercially marketed in the United States (other than in a test market) as of Feb. 15, 2007, or is a product previously found to be substantially equivalent by FDA and in compliance with the requirements of the Food Drug & Cosmetic Act (FD&C Act).
What should be included in an amended SE report?
Any amendment should include a cover letter that includes the submission tracking number (s) of the amended SE Report in the subject line. If responding to a deficiency (including requests), follow the instructions as outlined in your deficiency letter.
What is a predicate tobacco product?
A predicate tobacco product is one that was commercially marketed in the United States (other than in a test market) as of Feb. 15, 2007, or is a product previously found to be substantially equivalent by FDA and in compliance with the requirements of the Food Drug & Cosmetic Act (FD&C Act). Note: *New tobacco products commercially marketed …
When did the FDA withdraw the tobacco product application rule?
On Jan. 19, 2021, the Premarket Tobacco Product Applications final rule and Substantial Equivalence final rule were displayed in the Federal Register, but did not publish. On Jan. 20, 2021 a memo from the White House Chief of Staff ordered the withdrawal of any rules that did not publish in the Federal Register by noon on that day. Therefore, these final rules have been withdrawn. The FDA will work closely with the new administration to advance appropriate regulations and policies that were withdrawn and are in line with the agency’s public health mission.
When did provisional tobacco products come out?
Note: *New tobacco products commercially marketed after February 15, 2007 but before March 22, 2011 with an SE Report submitted by March 22, 2011 are known as provisional SE tobacco products— these may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent.
Can FDA process electronic documents?
Be submitted in an electronic format that FDA can process, read, review, and archive, unless FDA has granted a waiver.
How long does it take to get approved for a FDA abbreviated report?
In order to legally market, the applicant must (1) submit an Abbreviated Report; and (2) ninety days must pass since FDA’s receipt of the Abbreviated Report. 2. The Acceptance letter contains the notification of the 90-day timeline that must elapse prior to introduction.
Why is an SE report not necessary?
A detailed explanation of why an SE Report is not necessary to ensure that permitting the tobacco product to be marketed would be appropriate for protection of the public health. An environmental assessment prepared in accordance with the requirements of § 25.40.
How is a tobacco product modified?
The new tobacco product is modified by adding or deleting a tobacco additive or increasing or decreasing the quantity of an existing tobacco additive;
What does “add a tobacco additive” mean?
adding a tobacco additive; deleting a tobacco additive; increasing the quantity of an existing tobacco additive; or. decreasing the quantity of an existing tobacco additive. A detailed explanation of why the modification is a minor modification of a tobacco product that can already be sold under the FD&C Act.
What is the second step in the FD&C process?
Step 2: Submit an Abbreviated Report. Abbreviated Report: Step Two in the exemption process, the Abbreviated Report must be prepared after an Exempt Order is issued and is required to legally market a new tobacco product. It should include information demonstrating that: The product is in compliance with the FD&C Act.
What happens once a Substantial Equivalence Report is submitted to FDA?
Once a Substantial Equivalence Report is submitted FDA will review the report and determine whether or not the tobacco product is substantially equivalent and in compliance with the requirements of the FD&C Act. Before a new tobacco product may be commercially marketed under this pathway, the company must submit a report and FDA must issue a written order permitting the product to be marketed ( Section 910 (a) (2) ).
Who may submit a Substantial Equivalence Report?
A manufacturer of a new tobacco product may submit a Substantial Equivalence Report if that manufacturer believes that its tobacco product is substantially equivalent to a predicate tobacco product.
How does the FD&C Act define substantial equivalence?
Substantially equivalent or substantial equivalence, as defined by Section 910 (a) (3) (A) of the FD&C Act, refers to comparisons between a tobacco product and a predicate product when the tobacco product has:
What happens if FDA does not receive a Substantial Equivalence Report for a new tobacco product that the manufacturer is commercially marketing?
Continued marketing of adulterated and/or misbranded tobacco products may result in FDA taking regulatory action , including but not limited to, civil money penalty , no-tobacco-sale order, seizure, and/or injunction.
What does the FDA order mean?
The order means only that FDA has found that the new tobacco product is substantially equivalent to a predicate product and in compliance with the requirements of the FD&C Act. This web content highlights provisions of the Food, Drug and Cosmetic Act (FD&C Act). It is not intended to be comprehensive or reflect FDA’s interpretation of the Act.
What is a new tobacco product?
A new tobacco product is defined under Section 910 (a) (1) of the FD&C Act as “any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007 ; or any modification (including a change in design, any component, any part, or any constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the United States after February 15, 2007.”
Can you legally market a tobacco product?
In that case, you may not legally market your product under this pathway. You may submit an application seeking permission to market your new tobacco product under the Premarket Tobacco Application provisions under Section 910 of the FD&C Act.
Overview of Se
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A Substantial Equivalence (SE) Report can be submitted by any manufacturer for any new tobacco product seeking an FDA substantially equivalent order, under section 905(j) of the Federal Food, Drug, and Cosmetic (FD&C) Act. A substantially equivalent tobacco product is one that has been found by FDA to have either the same characteristics as a predi…
Preparing An Se Report
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An SE Report must meet the content requirements specified within the SE Final Rule, (per 21 CFR 1107.18(a)). The following is not meant to be an exhaustive list of all requirements for an SE Report, but rather highlights information for the new product and predicate product commonly omitted by applicants. An SE Report should include: 1. General information, such as: 1.1. Manuf…
Se Review Process
- Acceptance of an SE Report for Review: An administrative review that ensures the product falls under Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirem…
- Notification: FDA evaluation to ensure the predicate tobacco product is eligible.
- Substantive Review: FDA evaluation of the scientific information and data in an application.
- Acceptance of an SE Report for Review: An administrative review that ensures the product falls under Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirem…
- Notification: FDA evaluation to ensure the predicate tobacco product is eligible.
- Substantive Review: FDA evaluation of the scientific information and data in an application.
- Action:
Se Decisions
Se Resources
- Rule
- Guidance
- Reference Tools
Overview of Exemption Requests
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An EX REQ can be submitted by the original manufacturer for any new tobacco product seeking an FDA exemption order, under section 905 (j)(3) of the Federal Food, Drug, and Cosmetic (FD&C) Act. A new tobacco product may be considered for an exemption from Substantial Equivalence (SE) if FDA determines that: 1. The new tobacco product is modified by …
Preparing An Exemption Request
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Step 1: Prepare an EX REQ 1. An EX REQ includes (as required by21 CFR 1107.1): 1.1. The manufacturer’s address and contact information 1.2. Identification of the tobacco product 1.3. A detailed explanation of the purpose of the modification 1.4. A detailed description of the modification, including a statement as to whether the modification involves: 1.4.1. adding a toba…
Ex Req Review Process
- Acceptance Review: An administrative review that ensures the product falls under the Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of an appli…
- Notification: FDA review process when manufacturer proposes to modify a tobacco product legally marketed under a pending provisional SE Report or RFR status.
- Acceptance Review: An administrative review that ensures the product falls under the Center for Tobacco Products jurisdiction and confirms that the statutory and regulatory requirements of an appli…
- Notification: FDA review process when manufacturer proposes to modify a tobacco product legally marketed under a pending provisional SE Report or RFR status.
- Substantive Review: FDA evaluation of the scientific information and data in an application.
- Action:
Exemption Request Decisions
Exemption Request Resources
- Rule
- Tobacco Compliance Webinars for Manufacturers and Importers
- Reference Tools