FDA 510(k): Premarket Submission

510(k) approval: Premarket notification

 

General information on the FDA's main approval process

In contrast to the European legal area, the FDA knows an explicit approval of medical devices. The most prominent approval procedure is named after an article of the Food, Drug and Cosmetic Act (FD&C)510(k).

 

Fig. 1: The FDA distinguishes between different approval procedures, including the premarket notification PMN known as 510(k).

You can generally use this approval procedure if your product falls into Class II and if there is a comparable predecessor product, the so-called Predicate Device, which must actually be comparable. This is referred to as "substantially equivalent."

Learn more about these "Predicate Devices" below.

The 510(k) variants

 

The FDA distinguishes between three variants of premarket notifications:

  1. Traditional 510(k)
  2. The traditional approval process is used for "me too" products and serves as a fallback when FDA does not approve Special 510(k) and Abbreviated 510(k).
  3. Special 510(k)
  4. The Special 510(k) is an expedited process that can be used when making changes to your own product.
  5. Abbreviated 510(k)
  6. The Abbreviated 510(k) is a process built on compliance and adherence to standards, "Special Controls" and FDA "Guidance Documents."

Content and format of 510(k) submissions

Contents of a 510(k)

 

While there is no official format. However, manufacturers must follow the requirements of 21 CFR part 807 Subpart E. The FDA has a Guidance Document on the structure and content of 510(k) submissions published. Accordingly, the documentation should follow this chapter structure:

  1. Medical Device User Fee Cover Sheet (Form FDA 3601)
  2. Center for Devices and Radiological Health (CDRH) Premarket Review Submission Cover Sheet (Form FDA 3514).
  3. 510(k) Cover Letter
  4. Indications for Use Statement (Form FDA 3881)
  5. 510(k) Summary or 510(k) Statement
  6. Truthful and Accuracy Statement
  7. Class III Summary and Certification
  8. Financial Certification or Disclosure Statement
  9. Declarations of Conformity and Summary Reports
  10. Device Description
  11. Executive Summary/Predicate Comparison
  12. Substantial Equivalence Discussion
  13. Proposed labeling
  14. Sterilization and Shelf Life
  15. Biocompatibility
  16. Software
  17. Electromagnetic Compatibility and Electrical Safety
  18. Performance Testing - Bench
  19. Performance Testing - Animal
  20. Performance Testing - Clinical
  21. Other

Nearly identical claims can be found on the FDA's "Content of a 510(k).

Further information

 

You will find guidance on what each chapter should contain in the Guidance Document "Format for Traditional and Abbreviated 510(k)s ".

Format

 

The FDA specifies even the formatting such as paper size, perforation, and page margins. Among other things, it has published these "510(k) Format Tips".

510(k) for changes

 

The FDA refers to the TIR 45 on agile development in this context.

A (renewed) FDA clearance is necessary if there are changes in the intended use. New functions of the product are likely to be associated with such a change in the intended use.

And with function, functionality is meant, not a function/method of a program. There may well be "under the hood" changes that do not require a new 510(k) or at least allow a shortened 510(k).

"Predicate Device"

 

A Predicate Device is a medical device already (legally) marketed in the U.S. that medical device manufacturers can refer to for approval. Such a predicate device is a prerequisite for the 510(k) approval process preferred by manufacturers, which is much less complex than a PMA (premarket approval).

Proof of equivalence

 

For the manufacturer to cite this Predicate Device, it must demonstrate that it is substantially equivalent.

In most cases, however, manufacturers do not want to market an identical product (e.g., the Xth syringe), but one with the same or a similar intended use but differs more or less in its technical implementation.

The revised Guidance Document on Predicate Devices provides precise guidance on when you may cite a device as "substantially equivalent" and thus reference it as a Predicate Device for a 510(k) clearance (also called Premarket Notification). In doing so, the FDA looks at the following aspects:

  • Do the products have the same intended use?
  • Don't new questions arise about safety and efficacy?
  • Are the products equivalent? (technically, biologically, etc.)
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