How do you prove substantial equivalence?
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.
- has the same intended use as the predicate; and.
- has different technological characteristics and the information submitted to FDA;
What do you mean by substantial equivalence?
From Wikipedia, the free encyclopedia. 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.
What is the principle of substantial equivalence?
Definition: Substantial equivalence is a concept, first described in an OECD publication in 1993, which stresses than an assessment of a novel food, in particular one that is genetically modified, should demonstrate that the food is as safe as its traditional counterpart.
What are the two pillars of substantial equivalence?
The two pillars of substantial equivalence are ‘intended use’ and ‘technological characteristics’.
What is meant by the term substantial equivalence and how is it used to assess food derived from genetically engineered organisms?
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 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 does substantially equivalent to its conventional counterparts mean to the FDA?
In other words, substantial equivalence means that a new product must be the same as the non-genetically engineered crop except for the traits that were enhanced, added, or removed through genetic engineering.
What is a 510 K approval?
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act). Please note that FDA does not typically perform 510(k) pre-clearance facility inspections.
What is substantial equivalence in biotechnology?
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.
How to prepare a substantial equivalence ( SE ) report?
Substantial Equivalence 1 Overview of SE. 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 2 Preparing an SE Report. Determine a predicate product. 3 SE Review Process.
Can a CPA have a substantial equivalency?
Substantial Equivalency. Under Section 23 of the Uniform Accountancy Act (UAA), a CPA with a CPA license in good standing from a jurisdiction with CPA licensing requirements that are essentially equivalent to those outlined in the UAA (degree with 150 hours, minimum one year experience and successful completion of the Uniform CPA Examination)…
Why was the concept of substantial equivalency created?
The concept of Substantial Equivalency was developed to allow licensed CPAs to practice across jurisdictions more readily.
How is substantial equivalency determined in credentialnet?
Individuals who are licensed in jurisdictions that are not substantially equivalent may have their credentials evaluated by NASBA’s CredentialNet service to determine their individual substantial equivalency.