The Applied Technical Services Family of Companies (FoC) provides FDA 510(k) consulting services for medical device manufacturers pursuing FDA approval. Medical devices improve the quality of life for millions worldwide, and the United States is the world’s largest medical device market. The FDA mandates that devices sold in the US meet rigorous safety and performance standards and must be reviewed and authorized by the FDA for market authorization. Our regulatory consulting professionals support medical device companies through leveraging their expertise to optimize the FDA 510(k) submission process. We support our clients by ensuring their compliance with guidance documents and recognized standards, by providing insight from previous FDA interactions to proactively identify and address any pitfalls, and by minimizing risk all to help reduce the time to market and strengthen your overall regulatory strategy.
What is the 510(k)?
The 510(k) is a premarket submission that Class 2 (medium risk) medical device manufacturers provide to the FDA to demonstrate their product is “substantially equivalent” to a legally marketed predicate device. Manufacturers establish substantial equivalence by:
- Demonstrating that the device has the same indications for use as a predicate device and demonstrating that the subject device has similar technology and performance for the same intended use
- Verifying that any technological differences between the subject and the predicates do not pose new questions about the proposed device’s safety and effectiveness
Successful completion of the 510(k)-submission process will result in the FDA issuing a clearance letter, allowing the medical device manufacturer to place their device on the US market.
About Our FDA 510(k) Consulting Services
The 510(k) submission and subsequent review and approval process can be an overwhelming experience for device manufacturers. Our consulting services can alleviate this stress by providing guidance through the regulatory landscape with confidence. consulting services can help your business do the following:
- Confirm your device’s product code and regulation number
- Identify appropriate predicate devices
- Identify consensus standards, non-clinical and/or clinical data requirements, and FDA guidance documents applicable to your device
- Prepare a GAP analysis report by anticipating and addressing potential deficiencies
- Create and submit a comprehensive 510(k) submission package
- Communicate and support on responses to FDA review team
From identifying ideal predicates to preparing a complete comprehensive pre-market submission and managing communication with the FDA, our regulatory consulting services provide beginning-to-end support tailored to your device and goals. Let us streamline your path to FDA clearance. For more information regarding our medical device consulting services, call +1 (888) 287-5227.
