U.S. FDA Medical Device Services
The 510(k) Premarket Notification (PMN) and the De Novo Submissions are FDA's pathways for most Class II medical devices. 510(k) submitters compare their product to one that is currently legally marketed and demonstrate "substantial equivalence" in order to obtain clearance from FDA to market the device. Products for which there is no currently legally marketed device are submitted through the De Novo pathway.
IUVO Consulting helps companies obtain the necessary documentation for their 510(k) and De Novo submissions. We have cleared more than 40 devices via these pathways, which means we have the expertise to help our clients attain clearance they need for their devices quickly.
Each year between October 1 and December 31, the U.S. FDA requires manufacturers, importers, sterilizers, specifications developers, repackagers, relabelers, and others to register and pay a fee. Registered firms must also list the products that they are marketing in or importing into the United States.
IUVO Consulting helps companies register their establishments and list their products with FDA. We also help to facilitate the payment of FDA's annual Medical Device User Fees.
The U.S. FDA allows firms to request meetings with the agency before submitting a 510(k), IDE, De Novo, or Premarket Application. In fact, the agency recommends it to build relationships with industry and to facilitate more efficient reviews.
Pre-submission meetings can take 21 to 30 days to schedule, but the team at IUVO Consulting, facilitates the entire process for our clients -- including making the formal request, working with FDA to secure the meeting date, attending the meeting, managing notes and returning the minutes of the meeting to FDA to be entered into the official record.
Companies can obtain information about device classification and the applicable regulatory requirements by submitting a 513(g) Request for Information. Not only will FDA provide advice regarding the device status of the product, the agency will also provide a classification, product code, and state whether a submission is required prior to marketing.
IUVO Consulting assists firms that desire to obtain information from FDA about their medical device. We work with them to assemble the submission, and to answer any questions FDA may have to facilitate the agency's response.
Companies that are not based in the U.S. are required to designate a U.S. Agent, who is responsible for communicating directly with FDA on the company's behalf.
IUVO Consulting, LLC provides an affordable, annual U.S. Agent service, which assists companies as defined by FDA We also provide support to facilitate the release of products that are detained by FDA at the time of import in to the U.S.
When it comes to labeling medical devices, the U.S. FDA has requirements regarding what can and cannot appear on device labeling (marketing materials, packaging, affixed product labels, websites, etc.). FDA requires that labels provide clear instructions for use without misrepresenting what the device is able to safely and allowably do.
IUVO Consulting is able to review your labels to ensure that they meet FDA's requirements. We review each relevant section to alert you to information that may need to be added or removed. We can also assist with the design or re-design of your product's labels.