The Applied Technical Services Family of Companies (FoC) is an FDA 510(k) consultant helping medical device manufacturers earn FDA approval for their devices. Medical device manufacturers improve the quality of life of medical experts and patients who rely on their products. However, long before these devices reach their end users, they’re subject to rigorous regulations and guidelines that confirm their performance capabilities, reliability, and compliance. Our medical device testing lab is an excellent resource for manufacturers seeking to streamline their route to FDA approval.
What is the 510(k)?
The FDA 510(k) refers to the Federal Food, Drug, and Cosmetic Act’s section 510(k), which states that medical device manufacturers must provide the FDA with a premarket notification a minimum of 90 days before the manufacturer markets an eligible product. The purpose of the 510(k) is to grant manufacturers an opportunity to demonstrate that their product is “substantially equivalent” to a predicate device. A predicate device is a commercially available device that can be legally marketed in the US, and these devices serve as a basis for comparison for new medical devices arriving to the market. Manufacturers of the new devices must establish their devices’ substantial equivalence to a predicate device by doing the following:
- Proving the subject device’s intended use and technological characteristics are the predicate device
- Proving the subject device has the same intended use as the predicate and that any differences in technological characteristics do not present new questions regarding the device’s effectiveness and safety
About Our FDA 501(k) Consulting Services
The pathway to FDA approval is intensive and often stressful for medical device manufacturers to navigate. Our consulting services help streamline that process, enabling our clients to rest assured knowing that our experienced team members have the knowledge and resources to guide their devices toward market eligibility. Our consulting services support our clients by doing the following:
- Determining your device’s classification, product code, and regulation number
- Conducting a GAP analysis on documentation to address potential deficiencies
- Identifying the proper predicate devices
- Identifying testing requirements and required documentation
- Assisting in data collection and documentation processes
- Submitting paperwork to the FDA and responding to follow-up questions
Contact Us
Please call +1 (888) 287-5227 to learn more about how our FDA 510(k) consultants can help your medical devices achieve FDA clearance.
