With the intention of facilitating the placing on the market of safe, effective and high quality Medical Devices, last September 2018, FDA launched a new program pilot entitled Quality in 510 (k) or “Quik”. Through this program, the FDA aims to simplify the procedure for reviewing pre-market 510(k) requests for certain Medical Devices and to provide a final decision within 60 days from receipt of the requests.

A 510(k) request must satisfy all the criteria below to be admitted in the “Quik” Program:

  • The Primary Product Code of the device must be included in the list of devices identified by FDA.
  • The submission must be constructed using the “CDRH: Non-In Vitro Diagnostic Device – 510 (k)” template of eSubmitter.
  • The device must not be a combination product (i.e. device-drug or device-biological product).
  • CDRH (Center for Devices and Radiological Health) must be the reference Center for requests.

Only types of Medical Devices well-known by the FDA have been included in the official list of Primary Product Codes eligible for the “Quik” Program.

The “Quik” Program Pilot entails:

  • Preparation of the 510(k): the hardcopy cover letter accompanying the submission (on electronic support) must contain a mandatory statement requesting the inclusion of the submission in the “Quik” Program;
  • Submission procedure: the request must be constructed using a specific eSubmitter software template. The content of the submission does not change;
  • Reviewing process: for requests eligible to the “Quik” Program, both Traditional and Abbreviated 510(k)s, only the interactive review is provided. FDA expects the applicants to respond quickly to any requests for additional information (within 5-7 days). If, at any time during the review, the submission is no longer suitable for “Quik”, it will be converted into a normal 510(k) lasting 90 days and subject to eCopy requirements.

The “Quik” Program pilot will be active for a period between 3 and 6 months, to allow the Agency to collect enough data to evaluate both the efficiency of the Program itself and the ability of the eSubmitter software to structure the 510(k) requests to facilitate the review process.

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