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FDA Changes to 510(k) and De Novo Submissions

On August 14, FDA issued a draft guidance regarding the evaluation of automatic class III designation, otherwise known as de novo classification. The guidance details a recent change in the requirements for submitting de novo classification request.  A new type of device is automatically classified as class III, regardless of its risk, if no similar device exists to guide FDA in classifying it. De novo classification refers to a process through which the manufacturer of a device that is automatically classified as class III can request that FDA reclassify the device as class I or II. According to the guidance document, such devices had to first be found “not substantially equivalent (NSE) to legally-marketed predicate devices through a premarket notification (510(k)).” Now, however, de novo classification requests may be submitted with or without a preceding 510(k).

Along with the change in submission requirements, FDA created a new public database for de novo requests. De novo submissions are now logged separately from 510(k) submissions. Also, FDA will now send most interim and final decisions about 510(k) and de novo submissions strictly through e-mail, so it’s more important than ever for applicants to include their e-mail address on their cover letters. FDA will also now accept a change in whom they contact regarding submissions via e-mail if the change is made before final decisions are rendered.

Most medical devices require a 510(k) to obtain clearance from FDA for commercial distribution in the U.S., though there are some exemptions. There is no form for a 510(k), but it does require a specific format and extremely detailed information about the submitted device. FDA even requires that proposed labels, product manuals, and advertisements be included with the paperwork. It’s common for a 510(k) to contain over a hundred pages. Registrar Corp offers a 510(k) Administrative Review and Submission Service to help companies avoid incomplete submissions and costly delays. The service includes verification of the structure, format, and required elements of a 510(k), and a review of the labels and guides to be included with the 510(k) submission. Registrar Corp will even submit the 510(k) to the FDA and facilitate the user fee payment.

Registrar Corp is an FDA consulting firm that helps companies comply with FDA regulations. For assistance with 510(k) and de novo submissions, contact Registrar Corp at 1-757-224-0177 or receive online Live Help 24 hours a day from our regulatory specialists: http://www.registrarcorp.com/livehelp.