Manufacturers of class II and a few class I class III medical devices must receive FDA 510k clearance before their product can be legally sold in the United States.
Role of Biocompatibility Testing in FDA 510k Clearance
Biocompatibility is defined as the ability of the material or a medical device to be compatible with the living tissue. It is also said to be a material or device which does not produce harm or risk when in contact with the human body.
Chemical characterization is the process of identifying and determining the composition, structure, and properties of substances or materials through literature review or chemical testing as part of an assessment of the overall biological safety of a medical device.
The characterization process involves a combination of analytical techniques and methodologies to understand the chemical nature of a substance.
Performance Tests
The objective of the performance test is to Study the risks that are predicted from the design of the device and know any risk of the device type, and any new risks that may have emerged in prior investigations, and it can evaluate the efficacy of the medical device or to demonstrate proof of principle.
Performance clinical test is intended to find out the clinical safety and effectiveness of the medical device. Mainly this test is conducted on high-risk medical devices and tests performed in human beings. Clinical performance studies could be two types observational and interventional study.
Clinical testing typically depends on many factors including device type, intended use, design, safety profile, and clinical experience. Study considering the significant risk clinical study conducted under the IDE regulation If the clinical study considered no-significant study must conducted under the abbreviated requirements.
What is an MDUFA FOR 510K Clearance?
The Medical Device User Fee and Modernization Act (MDUFMA or MDUFA) is a set of agreements between the Food and Drug Administration (FDA) and the medical device industry to provide funds for the FDA to review medical devices.
Every five years, MDUFA must be reauthorized with adjusted fees and new guidelines that aim to streamline the review process. Industry leaders and the FDA are currently in discussions on proposals to include MDUFA III as MDUFA II is set to expire on September 30th, 2012.
Predicate Device for FDA 510k Clearance
The FDA developed this document to guide industry and FDA personnel on best practices for selecting a predicate device for premarket notification 510k submission. This guidance contains four best practices to keep in mind when selecting a predicate device to support a 510(k) submission.
These recommendations aim to improve the predictability, uniformity, and transparency of the 510(k) Program. These best practices are intended to promote the growth of safer and more effective medical devices under the 510(k) Program throughout time.
The FDA publishes the 510(k) Premarket Notification Database, which includes all devices cleared through this process. This online database is updated regularly by the FDA. To identify valid predicate devices, submitters typically use basic administrative information such as trade names, manufacturers, 510(k) numbers, and classification information (e.g., product codes, and classification regulation).
After identifying legally marketed devices, the FDA suggests evaluating the publicly accessible 510(k) Summary and Indications for Use documents for each device under consideration as a valid predicate device. In addition to these fundamental administrative requirements, the FDA suggests submitters use the recommended practices listed below when selecting a predicate device.
MR Compatible
Any medical equipment or devices used in the MRI environment must be specifically designed to be safe in the presence of strong magnetic fields. This includes patient monitoring equipment, anesthesia machines, and other medical devices.
Team I3CGLOBAL provides turn-key solutions for FDA 510k Clearance. We are 510k Consultants and US Agents. Contact us for more information.
