Frequently Asked Questions
Here are the answers for all of your questions about BIOREG services and regulation in the US (FDA), EU (EMA), CA (Health Canada) and Israel (Israel MoH).
About BIOREG Services
We are a regulatory affairs consulting firm dedicated to providing full regulatory support to medical device, combination and medicinal products. The focus of our practice is to advise on all regulatory matters relating to the US (FDA), European Union (EMA), Canada (Health Canada) and Israel (Israel MoH).
BIOREG’s strategic advantage is in its ability to identify easy and innovative solutions within a regulatory milieu. The firm examines all the potential regulatory avenues available to a client to determine and develop the most beneficial strategies for the product in each individual case.
Regulation Terms You Need to Know
BIOREG delivers highly individual solutions for regulatory affairs to the medical device and biotechnology companies. For a more in-depth perspective on how we help our clients, we have highlighted some of our recent projects as case studies.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device that is not subject to PMA. Submitters must compare their device to one or more similar legally marketed devices and make and support their substantial equivalency claims.
A legally marketed device is a device that was legally marketed prior to May 28, 1976 (preamendments device), for which a PMA is not required, or a device which has been reclassified from Class III to Class II or I, or a device which has been found SE through the 510(k) process. The legally marketed device(s) to which equivalence is drawn is commonly known as the "predicate" device. BIOREG provides regulatory services covering a broad range of technologies to many small and mid-sized companies who are struggling to achieve the fast regulatory approval which will maximize the marketing potential of their product. Get in touch to find out more about our Pre-Approval services we can provide!
Usually, clinical data comprise the safety and/or performance information that is generated from the clinical use of a device. Clinical data are sourced from the clinical investigation(s) of the device concerned; clinical investigation(s) or other studies reported in the scientific literature, of a similar device for which equivalence to the device in question can be demonstrated; or from the published and/or unpublished reports on other clinical experience of either the device in question or a similar device.
Clinical evaluation is a methodologically sound ongoing procedure to collect, appraise and analyse clinical data pertaining to a medical device. It ensures that the evaluation of safety and performance of the device is based on sufficient clinical evidence throughout the lifetime of the medical device on the market. Clinical evaluation is a responsibility of the manufacturer and its requirements apply to all classes of medical devices in EU.
Clinical Evaluation Report should clearly outline the conclusions reached about the safety and performance of the device from the clinical evaluation, with respect to the intended use of the device. You should state whether the clinical evidence demonstrates conformity with relevant Essential Requirements, that performance and safety of the device as claimed have been established and finally, that risks associated with the use of the device are acceptable when weighed against the benefits to the patient.
Post Market Surveillance include all planned activities carried out by the manufacturers to institute and keep up to date a systematic procedure to proactively collect and review experience gained from their devices placed on the market, made available or put into service for the purpose of identifying any need to immediately apply any necessary corrective or preventive actions. PMS system routinely monitors the clinical performance and clinical safety of the device. As for clinical evaluation, the scope and nature of PMS should be appropriate to the device and its intended purpose. New data generated through PMS process should be fed into the clinical evaluation process in a timely manner. While clinical evaluation requires data from PMS activities, it also generates new information that have to be fed into the PMS and risk management process.