510(k) Testing & Consulting
Successful FDA 510(k) submissions are critical to your market success. Incomplete or inaccurate submissions can lead to failure and may delay your product launch. Partner with Element for expert 510(k) testing and consulting. We guide medical device manufacturers through submission, testing, and documentation.
What is 510(k) Testing & Consulting at Element?
510(k) or Premarket Notification (PMN) sections of the Food, Drug and Cosmetic Act require manufacturers to notify the FDA of their intent to market a new medical device 90 days before market release. Specifically, medical device manufacturers must submit their 510(k) or PMN if they intend to introduce a device into commercial distribution for the first time or are reintroducing a device with significant changes that could affect its safety. Such changes can include modifications to design, material, chemical composition, energy source, manufacturing process or intended use. Element’s end-to-end service from testing through to consulting assures FDA submission success.
What can Element offer you for 510(k) Testing & Consulting?
Products We Test
Products We Test
Our comprehensive 510(k) testing services cover medical devices, combination devices, and their components. We test mechanical parts, electronic components, device materials, drug-device interfaces, and packaging materials. Our expertise extends to both standard medical devices and those requiring specialized testing protocols for unique materials or innovative designs.
Key Tests Offered
Key Tests Offered
Element offers an extensive range of testing and consulting services to help you obtain market clearance, including chemical and mechanical testing to pharmaceutical testing for combination devices. Working closely with your regulatory team, we help you select appropriate tests for your 510(k) submission. In addition to commonly used standards, our Engaged Experts can formulate non-standard test protocols for evaluating specific functional aspects of devices for which there are no standardized tests.
For more information about our FDA 510(k) testing and medical device consulting services or to request a quote, contact us today.
Methods And Solutions Offered
Methods And Solutions Offered
Our integrated approach combines expert testing services with strategic consulting to ensure successful 510(k) submissions. We work closely with your regulatory team to select appropriate tests, document outcomes, and prepare comprehensive submissions. Our experts guide you through the entire process, from test selection to final documentation, helping prevent delays and submission failures.
Which Labs Offer This Service
Which Labs Offer This Service
Our team operates from Life Sciences hubs across the world, providing global access to our expert capabilities. Find your nearest Life Sciences hub on our Locations Page.
Expert Consulting Services
Expert Consulting Services
Our Engaged Experts provide specialized guidance throughout your 510(k) submission process. We help navigate complex FDA requirements, select appropriate predicate devices, and develop testing strategies. Our consulting team works alongside your regulatory department to ensure all submission requirements are met, reducing the risk of delays or rejections.
Standards we test to and materials we test
- Required Submission of Safety and Effectiveness Information for Certain Class III Devices
- FDA-Cleared Sterilants and High-Level Disinfectants with General Claims for Processing Reusable Medical and Dental Devices - March 2009 [ARCHIVED]
For more information on 510(k) clearances, please visit www.fda.gov.
In addition to commonly used standards, our Engaged Experts can formulate non-standard test protocols for evaluating specific functional aspects of devices for which there are no standardized tests.
Medical Device Components
- Active Medical Device Components
- Electrical/Electronic Components
- Mechanical Components
- Structural Elements
- User Interface Components
- Display Systems
- Control Mechanisms
- Sensors and Monitoring Elements
Base Materials
- Medical-Grade Polymers
- Biocompatible Metals
- Composites
- Ceramics
- Glass Components
- Elastomers
- Coatings and Surface Treatments
- Adhesives and Bonding Materials
Combination Device Materials
- Drug-Device Interfaces
- Drug Delivery Components
- Drug-Contact Materials
- Drug Storage Components
- Drug Release Mechanisms
- Barrier Materials
- Controlled Release Systems
Sterile Components
- Sterilizable Materials
- Sterile Barriers
- Sterilization-Compatible Components
- Single-Use Components
- Reusable Device Materials
Packaging and Storage
- Primary Packaging Materials
- Secondary Packaging Components
- Storage Containers
- Protective Materials
- Transport Security Components
- Environmental Barrier Materials
- Shelf-Life Test Materials
Your Challenges, Our Solutions
Failed Submissions Delay Market Launch
Complex Testing Requirements Overwhelm Resources
90-Day FDA Timeline Pressures
Proving Device Equivalence Challenges
Why Choose Element
Complete Testing & Consulting Package
Expert-Guided Custom Solutions
Direct Support From Industry Leaders
Trusted Partner for Medical Devices
Frequently asked questions
What is a 510(k) submission?
Successful FDA 510(k) submissions are critical to your market success. Incomplete or inaccurate submissions can lead to failure and may delay your product launch.
Appropriately selected 510(k) testing of the predicate and submitted device must be designed and performed with the outcome documented and reported to demonstrate equivalence.
We walk you through the best approach to 510(k) submissions in our article, 5 Ways to Ensure your 510k Submission Testing Goes off Without a Hitch.
How can Element help ensure my 510(k) submission succeeds?
Element provides comprehensive testing and regulatory consulting services tailored to your specific device. Our experts work directly with your team to select appropriate tests, document results, and prepare submission materials that demonstrate substantial equivalence to predicate devices.
What happens if my 510(k) submission is incomplete?
Incomplete or inaccurate submissions can lead to FDA rejection, causing costly delays to your product launch. Our team helps you avoid these pitfalls through thorough testing and documentation preparation.
Explore our global network of labs and find your nearest location
VIEW ALL LOCATIONSRelated services
Pharmaceutical Medical Device and Product Testing
With Element as your medical device testing partner, you’ll enjoy the benefit of a single comprehensive supplier across feasibility, R&D and prototype trials, through product development, regulatory validation and production quality control.
Medical Device Regulatory Services
Element offers expert medical device regulatory consulting, guiding you through design, risk analysis, and FDA submissions for efficient product approval.