Services

510(k) Data Packages and Support

iFyber offers both standard and custom preclinical efficacy testing and data packages that can be submitted to FDA in support of substantial equivalence decisions for traditional medical devices and combination products, such as wound dressings and coated devices. iFyber has a GLP-compliant quality system and can provide GLP testing services upon request.

Most performance claims are based on in vitro testing; however, the FDA does not recognize any in vitro antimicrobial effectiveness testing standards that can be directly applied to antimicrobial wound dressings without modification. Companies must define what is appropriate for their specific device and provide adequate justification. All testing must be completed on the final product configuration at the end of the shelf-life and conditioned to emulate factors of clinical use.

iFyber specializes in designing and executing customized test methods suited to your needs. We can help you identify worst-case and clinically relevant test articles, as well as develop and execute customized testing to fit the intended use of your product.

Explore iFyber's 510(k) Data Package Services:

Efficacy data packages and support for 510(k) Submissions
Characterization and validation of supercritical CO₂ sterilization methods
In vitro antibacterial efficacy testing
Performance test method development, selection, and execution
Modified AATCC test method 100
Identification of worst-case scenario test articles

In addition to 510(k) testing and data packages, iFyber offers full-service Quality and Regulatory consulting.

NON-GLP, GLP, GMP, & GCP

What's the difference?

Studies that are performed to determine product performance and not product safety can be non-GLP (e.g., custom antimicrobial testing, chemical characterization).

Product safety testing (e.g., cytotoxicity, sensitization, and implantation) that utilizes an animal, plant, or microorganism test system intended for FDA submission must be performed using Good Laboratory Practice (GLP).

To determine whether the product meets manufacturing specifications, Good Manufacturing Practice (GMP)-compliant testing and controls are used. This testing can include bioburden, sterility, stability/shelf-life, and process validations.

If clinical trials are performed, they must follow Good Clinical Practice (GCP) to protect the rights, safety, and welfare of human participants and ensure the quality, reliability, and integrity of data collected.

What Testing Do You Need in Your 510(k)?

Example: Wound Dressings Combined with Drugs

Most performance claims are based on in vitro testing; however, the FDA does not recognize any in vitro antimicrobial effectiveness testing standards that can be directly applied to antimicrobial wound dressings without modification.

Companies must define what is appropriate for their specific device and provide adequate justification.

All testing must be completed on the final product configuration at the end of the shelf-life and conditioned to emulate factors of clinical use. iFyber can help in identifying these worst-case and clinically relevant test articles and developing and executing customized testing to fit the intended use of your product.