Pre-market Notification: 510(k)

Manufacturers wishing to introduce Class II medical devices, and some types of Class I and III devices to the US market must submit a 510 (k) application to the FDA.
The 510 (k) is also required in case of significant changes that have impact on the safety or effectiveness of the device already cleared by the FDA, for instance, in case of changes to the intended use, technology changes, etc ...Maytal, based on the experience gained in over 10 years of work with the FDA, is able to help the company through three basic steps towards the successfull outcome of a 510 (k) application:
  • Gap analysis to present a 510 (k), assisting the company in the verification and/or re-definition of the Intended Use for the US market, identification of the Predicate Devices, identification of the guidelines and specific rules for FDA, identification of the documents necessary for the 510 (k) and analysis of those available in the company, to assess suitability and completeness, estimate the probability of success of the practice and/or of any inconveniences, together with the client, and, if needed to propose alternative or precautionary approaches, such as the pre-submission, or the De Novo.
  • Technical-regulatory consultancy, thanks to its technical experts (engineers, biologists, clinicians) to support the company in the development/adjustment of existing documentation such as:
  • Drafting of the dossier fo filing the "510 (k) application. When all the documents and information requested are ready, MAYTAL will be able to prepare the file for the final presentation of the 510 (k) to FDA and will support the company in responding to the FDA objections, until obtaining the 510 (k) clearance.
Once the clearance is obtained, Maytal will be able to support the manufacturer of medical devices in the registration of head office and device listing.