In a recent quarterly 2015 report, the US Food and Drug Administration (FDA) stated that major deficiency letters were issued to 67% of premarket approval applications. Such deficiencies in applications can hold up premarket approvals - sometimes more than 180 days.
It is worthwhile to explore if such delays can be avoided by submitting accurate and good quality applications to the FDA.
The Center for Devices and Radiological Health (CDRH), a division of the FDA, ascertains the safety and effectiveness of medical devices prior to their marketing. The CDRH also provides various guidance documents and advice to the medical device industry regarding basic requirements for the approval.
Depending on the type of medical device, an appropriate premarket submission needs to be filed. Here we discuss two most common types of premarket submissions:
510 (k) Submission or Premarket Notification:
In order to demonstrate safety and efficacy of a premarket medical device, that is almost equivalent to a legally marketed medical device, a 510 (k) submission is submitted. The details of legally marketed devices are described in the Code of Federal Regulations 21 CFR 807.92(a)(3). The claim of equivalency must be supported with extensive and meticulous documentation.
Most medical devices file premarket submissions under this category. A company must wait for the FDA approval letter before it markets a medical device and usually, for a good quality premarket submission, this wait time is approximately 90 days.
Premarket Approval (PMA):
The FDA website categorically states that the PMA application is the most stringent type of application. These applications must follow regulations stated in the Title 21 Code of Federal Regulations (CFR) Part 814, Premarket Approval.
Moreover, PMA submissions are charged substantially higher fees as compared to 510 (k) applications.
When a manufacturer or an innovator wants to market Class III medical devices, it has to file a PMA submission. Class III medical devices help to sustain human life but may also present risk to human life.
PMA submissions are necessary to ensure that these Class III devices are safe and effective in supporting human life. These submissions need to be backed with scientific data and other evidence.
In general, the FDA advisory committee reviews these applications within 180 days but depending on the quality of submission and/or type of device, it can take longer time.
Apart from these two common scenarios, medical device companies may occasionally need to file premarket submissions such as De Novo classification or pre-subs for their products. Further, they may need to communicate with the FDA regarding 100 day meetings or letters as applicable.
To sum up, determining the type of submission, further compiling an application, and ultimately, completing the process, requires a good understanding of regulatory requirements.
Consultation for Premarket Submissions
The likelihood of an approval (“clearance”) of a premarket submission is higher when the associated documents are accurate, complete and adequate. For start-ups or companies operating on a limited budget, in-house expertise to compile these regulatory submissions may not be available. It is advantageous to consult experts for the preparation of the documentation needed for FDA registrations such as 510(k) and premarket approvals (PMA).
At GxP-CC, our regulatory and compliance consultants have up-to-date information of regulatory requirements that are necessary for a successful premarket submission. Manufacturers and innovators can benefit from this expertise as the documentation of premarket submissions is reviewed carefully for its completeness and accuracy.