The United States Food and Drug Administration (U S F D A) has introduced the PreSTAR (for early submission requests), which is an extension of the eSTAR program, as a beta version of the latter to simplify pre-submissions to the Center for Devices and Radiological Health (CDRH). This program aims to standardize the submission format and thereby enhance the review process and quality of submissions. The PreSTAR program is currently in the beta stage and is available for voluntary use by medical device applicants.

What are the Differences Between eSTAR and PreSTAR?



An accessible tool for medical device applicants seeking to submit their 510(k) and De Novo submissions to either the CDRH or the Center for Biologics Evaluation and Research (CBER).

A tool through the U S F D A aims to simplify pre-submissions to the CDRH.

An interactive PDF form that assists applicants in creating a thorough medical device submission.

Specifically designed to establish a uniform format for pre-submissions.

Enhances the quality of incoming submissions for a wide range of medical devices.

Currently in the beta stage, it aims to enhance the review process and quality of submissions.

What are the Benefits of using the PreSTAR Program for Medical Device Submissions?

Utilizing the PreSTAR program ensures thorough and compliant pre-submissions, expediting the review process and ensuring timely access to safe, effective, and high-quality medical devices. Some of the key benefits of using this program are:

  • A Streamlined Review Process: By offering a uniform pre-submission format, the PreSTAR program can help simplify the review process, which will, in turn, lead to saving of time and costs for medical device companies.
  • Improved Quality of Submissions: The PreSTAR program aims to boost the quality of submissions for various medical devices by ensuring comprehensive, high-quality data for the CDRH’s pre-market review. By employing the PreSTAR program, medical device firms can submit applications that are complete, accurate, and compliant with all the requirements, which will, in turn, reduce the need for extra administrative reviews and revisions.
  • Ease of Use: The PreSTAR program is user-friendly, offering automation, content alignment with the CDRH templates, and step-by-step guidance for each submission section. Thus, it helps ensure that medical device firms complete their pre-submissions accurately and efficiently, minimizing errors and saving time.
  • Expediting Feedback from the USFDA: By enhancing the quality of submissions and expediting the review process, the PreSTAR program enables medical device companies to expedite feedback from the USFDA. This, in turn, reduces the amount of time and resources required in the development process.

What are the Requirements for a Pre-submission using PreSTAR?

While the PreSTAR program maintains the same pre-submission requirements as the standard process, it offers the added advantage of a standardized format, along with user-friendliness. Here are the critical requirements of PreSTAR in terms of format, content, and standardization:

  • Format and Content: The PreSTAR program’s format and content standards are identical to those of regular pre-submissions. They aim to standardize the format and enhance the quality of submissions, thereby streamlining the review process.
  • Standardized Format: The PreSTAR program offers a standardized format for pre-submissions. As mentioned earlier, it is user-friendly and easy to use, featuring automation, content alignment with the CDRH review templates, and step-by-step guidance for each submission section.

Medical device companies can benefit by using the PreSTAR program, as it can help them streamline the review process, improve the quality of their submissions, and enable them to expedite feedback from the USFDA; in addition, the program is user-friendly and easy to use. However, it is important to avoid common mistakes in pre-submissions to the US FDA. It must be noted that although presently optional, the USFDA plans to make PreSTAR mandatory for specific submissions in the future. To know more about PreSTAR, reach out to our Regulatory experts today. Stay informed! Stay compliant!