Have you chosen correct FDA Regulatory Pathway for Your Medical Device?

Most medical device professionals and corporations are acquainted with the well-known pathways for market access in the United States - the510(k) or pre-market notification andpremarket approval (PMA). The 510(k) has options to choose from – traditional, special & abbreviated 510(k)s. The PMA also includes subtypes – traditional, modular, and streamlined.

Medical device manufacturer have more options to bring their products to the market when compared to drugs or biologics.

Some of the lesser known pathways available to medical device manufacturers include de novo, humanitarian device exemption (HDE), product development protocol (PDP), custom device exemption (CDE) and compassionate use.

Manufacturers can choose either one pathway for their device or a combination of pathways based on the labelling of the device for which market clearance is needed. A well-traversed pathway can be used for bringing the device sooner to the market and later label expansion can be done to add additional indications for use and this clearance can be done by a different pathway. The regulatory strategy must be well planned so that devices can be brought to the market quicker and easier with lesser obstacles during the regulatory submissions.