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.

Buy the FDA PreSTAR Tutorial for $299

FDA PreSTAR Tutorial

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

• Clinical Thermometer (FLL)
• Drug Wound Dressing (FRO)
• OTC Pregnancy Test (LCX)

The PreSTAR tutorial was originally recorded in 2023, but now we are updating the PreSTAR tutorial series for v1.1. The PreSTAR template has changed very little since the initial beta version, but our team has submitted over 100 pre-submissions with the PreSTAR template, and we refined our process. The most significant change to the template was enabling the PDF template and resource for 513(g) submissions. That is covered in a different webinar–also included in our 510(k) Course.

Revision History of the PreSTAR template:

• PreSTAR v1.1 (2024-06-26): Modified the categorization of Application/Submission types. Updated list of Standards. Updated FAQ. Fixed minor bugs and typos.
• Update 1.0 (2024-03-29) from version 0.3: 513(g) submission content was enabled. The inclusion of more than 10 standards will no longer cause an Import to run very slowly. An attachment counter was added in the Verification section. A workaround was added to allow the proper display of an eSTAR in Adobe Acrobat Pro when it was prepared with PDF-XChange Editor and formatted text was copied to a textbox. The FAQ was updated. The list of standards, list of regulations, and list of product codes were updated. Other minor bugs were fixed and minor changes were implemented.
• Update 0.3 (2023-12-06) from version 0.2: Standard recognition number can now be used to autopopulate standard information. Updated Software guidance document link. Updated list of medical device product codes. Updated FAQ. Fixed minor bugs.
• Update 0.2 (2023-08-14) from version 0.1: Addition of PCCP submission topic category. Minor text changes.
• Updated 0.1 (2023-06-06): Initial beta release. 

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 PreSTAR Tutorial Kick-off – October 31, 2024

1. Introduction – What is an FDA PreSTAR?
   1. FDA Guidance
   2. FDA CCP
   3. Version (now version 1.1)
   4. Color-coded 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. Recognized Consensus Standards

PreSTAR Tutorial Part 2 of 4 – November 7, 2024

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

PreSTAR Tutorial Part 3 of 4 – November 14, 2024

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 – November 21, 2024

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

About  the  Instructor

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. From 2009 to 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 +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.