FDA PreSTAR Tutorial – How to get the most from your pre-sub

The Ultimate FDA pre-submission training is a four-part FDA PreSTAR tutorial that is included in our 510k Course.

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Buy the FDA PreSTAR Tutorial for $299

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This is a 4-part webinar series that will be conducted live on July 5, 13, 19, and 26 (2023) via Zoom. The second webinar was rescheduled from 12th to 13th due to a scheduling conflict. This FDA PreSTAR tutorial will be free to anyone that already purchased our 510(k) course. If you find this webinar series helpful, you can upgrade to our 510(k) course series and we will credit you for this purchase.
Price: $299.00

We published a comprehensive blog on Wednesday, June 28, 2023, about the FDA pre-submission process, but if you want the ultimate access to our FDA pre-submission templates that you need to attach to your FDA PreSTAR, this is the perfect training webinar for you. Everyone asks us for examples, so in this webinar series, we will be showing you how to complete the entire FDA PreSTAR for a device. If you would like to vote on which device we should use as an example (i.e., Option 1 = Infrared Thermometer or Option 2 = Antimicrobial Gauze), please place your vote on our LinkedIn page.

Outline for the Ultimate FDA pre-submission webinar series

Registrants will receive a confirmation email because we deliver content and notification of updates through AWeber as an email subscription. After confirmation, you will receive login information for the four live Zoom webinars. Each of the four webinars will be approximately 45 minutes in duration, and the training content is organized as follows:

FDA Pre-STAR Tutorial Kick-off

  1. Introduction – What is an FDA PreSTAR?
    1. FDA Guidance
    2. CCP
    3. Beta Version
    4. Key
    5. FAQ
    6. Version History
  2. Application/Submission Type
  3. Cover Letter / Letters of Reference
  4. Applicant Information
    1. Primary Correspondent/Consultant Information
    2. Correspondent/Consultation Information
    3. Pre-Submission Correspondence & Previous Regulator Interaction
    4. Standards

Session 2  of 4

  1. Submission Characteristics
    1. Submission Purpose
    2. Meeting Information
  2. Product Description
    1. Listing Product(s)
    2. In Vitro Diagnostic Assay and Instrument Information
    3. General Product Characteristics
    4. Description
    5. System/Kit Components and Accessories

Session 3 of 4

  1. Indications for Use
  2. Classification
  3. Labeling
    1. General Labeling
    2. Package Labeling
    3. Package Insert/Instructions for Use
    4. Other Labeling
    5. Specific Labeling
  4. References

FDA PreSTAR Tutorial Finale

  1. Pre-Submission Questions
  2. Verification
  3. Export Data
  4. Import Data
  5. Registration and Listing
  6. Delivery Directions

About Your Medical Device Academy Webinar Instructor Rob Packard

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Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. 2009-2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email. You can also follow him on YouTubeLinkedIn or Twitter.

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