Why the FDA Pre-Submission process is an under utilized tool.
The FDA Pre-Submission is a way for companies to request feedback from the agency on potential and planned medical device, biologics and drug submissions. It’s a great service to take advantage of, only we’ve found that it tends to get underutilized.
The Pre-Submission allows us to request formal feedback on your medical device before we make the move to submit our 510(k). This is known as a Q-Submission, which under the guidance published by FDA, allows you to request the following:
- Pre-Submission (what we’re focusing on here)
- An informal meeting
- An agreement meeting
- Other (such as submission issues or study risk determinations)
The Pre-Submission process was born out of a need to provide expanded access to the FDA and allow companies to get valuable feedback ahead of time. This can help to keep your company on-track for getting your device to market as soon as possible - it helps to be aware of possible issues ahead of time and deal with them before final submission.
In any case, the basic definition of what a Pre-Submission is remains the same. It is a formal written request from an applicant/sponsor for feedback from FDA to be provided in the form of a formal written response, meeting or teleconference in which the feedback is documented in meeting minutes.
It’s a great way to meet with the FDA, ask them some questions, then document that information for future use. It boils down to identifying key issues that are keeping you up at night, and making your overall submission process easier.
FDA continues to expand its Pre-Submission program to include a number of different medical device submissions that a manufacturer may choose for bringing a device to market. The comprehensive list of submission types is known collectively as Q-Submissions(Q-Subs), which include:
E, De Novo request, 510(k), Dual, BLA, IND), Accessory Classification Request, or CW.
- Investigational device exemptions (IDE)
- Premarket approvals (PMA)
- Premarket notifications (510(k)
- Dual
- HDE – Humanitarian Device Exemption
- De novo requests
- Clinical Laboratory Improvement Amendments (CLIA)
- Certain Investigational New Drug Applications (IND) and Biologic License Applications (BLAs)
The Pre-Submission program is a valuable tool that tends to be under utilized. Perhaps companies are put off by the idea that the process will take too much time and money, or they’re worried that FDA will tell them they need to do something that they hadn’t already planned on doing. (News flash: The agency will do this during submission, anyway.)
Our position is that a Pre-Submission generally makes good business sense. You have the opportunity to make yourself known to the FDA and can ascertain its position about things relevant to your submission.
Like many other medical device companies, you just may find it’s well worth the time and money.
Home Page Cover Image:
Veterinarian Dr. Michelle Myer from Vista Veterinarian Hospital in Kennewick, WA.
Seen here administering IsoPet® therapy to a feline suffering from a sarcoma.
RadioGel™ is a hydrogel liquid containing tiny yttrium-90 (90Y) phosphate particles that may be administered directly into a tumor. The hydrogel is an yttrium-90 carrier at room temperature that gels within the tumor interstitial spaces after injection to keep the radiation sources safely in place. The short-range beta radiation from yttrium-90 localizes the dose within the treatment area so that normal organs and tissues are not adversely affected.
IsoPet® Therapy Application(s)
Precision Radionuclide Therapy (PRnT)
Vivos Inc. - (OTCQB: RDGL) Investor Relations
Contact
| bg-primary | |
| bg-primary-light | |
| bg-primary-dark | |
| bg-secondary | |
| bg-secondary-dark |
| body | |
| top-header | |
| header | |
| content |
| background | |
| text color | |
| link color | |
| horizontal line |
| style 1 | |
| style 2 | |
| style 3 |
| social icons | |
| navigation color | |
| subnav background |
| background color | |
| navigation color |
Note: All changes made here will be applied to your entire website.
