Medical Devices and IVDs—Focus on US FDA 510(k)

Consulting for Medical Devices and IVDs—Focus on US FDA 510(k)

Filing a Premarket Notification with the FDA, also known as an FDA 510(k) submission is the primary step in marketing a Class II medical device or IVD in the US.

Technically, the FDA does not "approve" medical devices or IVDs for sale under the 510(k) process; the agency gives the nod for them to be marketed in the U.S. Please note that FDA approval and FDA clearance mean the same.

Premarket notification—who should submit? certificate?
  • Normally, device makers planning to market Class II medical devices including a small number of Class I and III devices or IVDs must submit a 510(k) to US FDA. A 510(k) premarket notification is also required for manufacturers changing the intended use of their medical device, or changing the technology of a cleared device in such a way that it may significantly affect the device's safety or effectiveness.
FDA 510(k) submission support from Pepgra

We apply a two-pronged approach to ensure a successful 510(k) submission. This approach is cost-effective for our clients, and it drastically reduces the possibility of failure to receive clearance of a 510(k) submission from FDA.

Step A: Pre 510(k) submission gap analysis and requirements evaluation

The proposed use and design of your medical device assists us to ascertain the proper FDA product code and regulation number, which may pertain to device-specific guidance documents or required standards.

  • Pepgra evaluates similar devices that already have FDA 510(k) clearance to determine whether any are suitable for use to determine substantial equivalence for your device. These are referred to as predicate devices. (NB).
  • We offer a product-specific list of documents and information needed for the 510(k) submission.
  • An assigned U.S. regulatory consultant will review the information to determine its suitability for the 510(k) submission.
  • After assessing this documentation, our CROs document a detailed gap analysis report identifying incomplete or missing information required for a complete 510(k) submission.

Once you receive the comprehensive gap analysis,Pepgra Healthcare can help you close these gaps and will review more information.

Step B:Compiling the dossier and FDA 510(k) submission

When all required documents and information have been received, Pepgra Healthcare will prepare your final 510(k) submission

  • Document a technical comparison of your medical device to the predicate device(s).
  • Prepare all 21 sections of the FDA 510(k) application.
  • Submit the hard copy and electronic copy of the 510(k) to the CDRH division within the FDA and act as the liaison for further communications with the FDA.
  • Coordinate payment of FDA 510(k) submission fees in your stead.
  • Inform you of all information received from the FDA following the 510(k) submission, and assist in answering their requests for more information as needed.

Succeed today in marketing your device to the US market; As a reliable CRO partner for medical devices and IVD, we have successfully prepared and submitted FDA 510(k) submissions for medical device and IVD companies across the globe who strive to sell in the US.

Request Pepgra CRO experts support on help dossier compilation and other documentation.

Pepgra is a leading CRO solutions for medical device manufacturers with offices across US, UK and India. Pepgra CRO experts offer assistance in all phases of clinical trials. Clinical research, regulatory affairs, regulatory writing, medical writing, Clinical Trial Protocols (CTP), biostatistical programming, trial patient monitoring, and Post-marketing Surveillance (PMS)—these are some of our offerings with niche therapeutic offerings as a key differentiating factor. Partner with Pepgra today; your reliable CRO partner. | +1-972-502-9262 |

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