Premarket notification procedure in the USA – part 2.

In the previous part of the article, we considered the purpose of premarket notification procedure, as well as what is meant by a substantially equivalent. In this part of the article, we will try to figure out what this notification consists of.

It is worth noting that the composition of the “registration dossier” for a premarket notification is described in sufficient detail in the Guidance for Industry and Food and Drug Administration Staff. In addition, the Guide contains an example of a dossier, as well as a decision-making flowchart regarding the issue of equivalence.

A typical medical device registration dossier consists of the following eight parts:

  • Information about submitter;
  • Information about MD;
  • Information about predicated device;
  • Device description;
  • Indications for use;
  • Performance data;
  • Conclusions.

The FDA goal to make a Decision for a 510(k) is 90 FDA Days. FDA Days are calculated as the number of calendar days between the date the 510(k) was received and the date of a decision, excluding the days the submission was on hold for a request.

The Center for Device Control and Radiological Health (CDRH) handles notifications and other matters related to medical devices. It also generates a list of devices that have passed the 510 (k) procedure. For each approved product, you can see the notification from the FDA, as well as brief information on the equivalent. For example, in January 2022, a new pregnancy test was approved by the FDA. Information on it can be found in the public domain at the link.

As for the fee, until September 30, 2023, it is $19,870 for large companies and $4,967 for small businesses.

It is important that the fee reduction is possible for companies that are recognized by the CDRH as small businesses.