Pre-market Notification or 510k is a technical file prepared and submitted to FDA for each medical device or IVD in the scope of clearance. A 510(k) contains detailed technical, safety, and performance related supporting evidences to demonstrate the device in question is “substantially equivalent” to a predicate device already cleared for sale in the united states.
The FDA expert will review the 510k file and “clear” your device when he finds the device is substantial equivalent
FDA classified the devices as follows
- Class I: Simple risk-free devices. Majority of the class 1 devices are subjected to general regulatory controls and does not require any 510k clearance.
- Class II: Devices pose a moderate level of risk to the user and majority of the class II devices require a 510k submission and clearance before they can be legally marketed.
- Class III: Devices pose a high level of risk to the user and could lead to significant adverse outcomes for the patients. Majority of the class III devices require a 510k submission and few require PMA submission before being marketed in the USA.
FDA 510(k) preparation and difficulties
Quality of the 510k matters!!! In terms of less review comments and fast clearance. FDA 510(k) technical file preparation can be challenging with the stricter requirements in terms of file structure covering 17 individual modules to address each 510(k) requirements. All relevant protocols, test reports, and other supporting evidences are provided in specified annexures with appropriate file numbering and appropriate title. Most of the 510(k)s are well over 250 pages. The FDA 510k must be suitable for FDA’s eCopy submission requirements.
Role of REGhelps in 510k submission and clearance
To ensure a successful 510(k) submission and clearance the role of consultants is very much vital. The following are the service we provide customers to reduce the cost, duration and failures in 510k submission.
- Pre 510(k) submission GAP analysis
- Document compilation and FDA 510K (Pre & Original) submission
- US Agent Service and Submission Service Only
Premarket approval (PMA) is the FDA process of scientific and regulatory analysis to assess the safety and efficacy of Class III medical devices. PMA is the strictest type of medical device marketing application required by the FDA. The medical device manufacturer or the seeker must receive FDA approval of its PMA application prior to marketing the device. The PMA approval is based on a decision by FDA that the PMA contains sufficient authentic scientific evidence to assure that the medical device is safe and effective for its intended use(s).
- 510k is needed when:
- Anyone who is intending to sell their medical device(s) in the USA must make an FDA 510k submission at least 90 days prior to contributing the medical device for sale, even though it may have been under development or on a clinical investigation before that date.
- Difference or change in the intended use for a medical device which you already have in commercial distribution. (Already cleared 510k)
- If there is a difference or modification of a legally marketed medical device and that change could significantly affect its safety or efficacy.
- A new 510k submission is required for changes or alterations to an existing medical device, where the alterations could significantly affect the safety or efficacy of the medical device or the medical device is to be marketed for a new or changed indication for use.
- Identify the predicate device
- Identify the FDA code and regulation number
- Identify the device class and method of 510k
- Perform Biological evaluation
- Review Risk analysis, Equivalent device data
- Review Labels and User Manual / IFU
- Review Shelf life records / life-time calculation
- Review preclinical study evidences
- Do an FDA Pre-submission
- Appoint US Agent and make 510k review payment to FDA
- Submit 510k in Hard copy and E Copy
- Respond to FDA queries till acceptance of 510k and issue of k number
Pre-submissions are made to the FDA for taking a feedback about the quality of file and its content. They are used for various intensions including meeting requests, to study risk determination, for submission issues, and for FDA feedback to specific questions related to a pending submission or protocol.
Average of 5 months
Consultation & Guidance starts from $ 12000 for a single file.
Annual US Agent Fees is $ 650