United States FDA 510(k) Premarket Notification Applications
Van Hoven Consulting specializes in authoring and submitting 510(k) premarket notification applications for new Class I or Class II medical products. Having authored numerous 510(k) applications for different medical products, Van Hoven Consulting offers a broad spectrum of experience and insight to help you put together a 510(k) application that will withstand, and pass, FDA scrutiny and review.
With FDA’s ever changing expectations for new medical product applications, Van Hoven Consulting is your partner in successfully navigating the FDA’s process for legally marketing your product in the United States. Don’t get stuck in FDA’s revolving door of questioning that can extend 510(k) clearance for months, if not years. Contact Van Hoven Consulting today to discuss your 510(k) submission strategy.
Van Hoven Consulting has a series of templates proven to meet FDA’s expectations. Don’t start from scratch writing a submission that may not contain the required elements, utilize Van Hoven Consulting’s 510(k) templates today to get your product through the FDA on their quickest timeline.
- Do you find the requirements for FDA’s Refuse to Accept Checklist or the e-submission process confusing and are unsure how it applies to your product?
- Do you have questions on which sections of the 510(k) application apply to your product?
- Is it unclear to you what product test data needs to be included in your application?
- Are you having a tough time determining your predicate device(s)? Or what testing of your product needs to be compared to the predicate(s) of choice?
- Does your submission need to include comparative testing?
- Do you need to identify appropriate testing labs?
- Do you question which standards apply to your product or how to fill out FDA forms (i.e. FDA Form 3654 and Form 3674) relating to standards referenced in your 510(k) application?
- Do you find the expectations for documented standards compliance unclear?
- Do you need someone to take your existing documentation and assemble it into a complete submission that will get through FDA’s Refuse to Accept Checklist and on to the substantive review process?
- Are you on a tight timeline for FDA clearance?
With FDA’s ever changing expectations for new medical product applications, Van Hoven Consulting is your partner in successfully navigating the FDA’s process for legally marketing your product in the United States. Don’t get stuck in FDA’s revolving door of questioning that can extend 510(k) clearance for months, if not years. Contact Van Hoven Consulting today to discuss your 510(k) submission strategy.
Van Hoven Consulting has a series of templates proven to meet FDA’s expectations. Don’t start from scratch writing a submission that may not contain the required elements, utilize Van Hoven Consulting’s 510(k) templates today to get your product through the FDA on their quickest timeline.