Nano Safe Coatings will establish a Device Master File (DMF) at the FDA for companies that want to apply our technology to their medical devices and products. This will help partners expedite the 510(k) or de nova process. The following Index is representative of what is in the Nano Safe Coatings DMF and is intended to give partners insights into the robust nature of the file, to help align the company's data needs and to simplify the processing of the application for use.
The Device Master File is a “living file” and there will be additions and upgrades consistent with the needs of our clients and any changes at the FDA.
Customers with medical devices must report to the FDA their use of our treatments and treatment processes as modifiers of their devices. To best facilitate the FDA’s review of the customer’s submission, a Device Master File on our product and process will save them time and money and help the FDA process their submission more expediently. This is accomplished by supplying key information about our treatments, their uses, safety and performance.
The FDA DMF provides Nano Safe Coatings protection for any proprietary information that is designated as such. This can include test results in the basic categories in the DMF, chemical characterization, marketplace information, competitive comparisons, manufacturing and application information and other data deemed proprietary.
The FDA DMF simplifies and speeds the process of FDA acceptance and the move to marketplace commercialization. Using device and claims specific equivalence data, the device manufacturer can link to the robust database in the Nano Safe Coatings DMF adding the processing of the application by the FDA. Access to the Nano Safe Coatings DMF is granted using a letter from Nano Safe Coatings granting the FDA use of the File for processing the application of the device manufacturer.
This part of the File provides an overview of the disruptive, unique, and patented nature of the Nano Safe Coatings technologies and application procedures. This dialogue emphasizes how the Nano Safe Coatings technologies address the unmet needs of safe and effective antimicrobial protection of medical devices without the problems of legacy toxicity, slow antimicrobial modes of action, non-target bio-interactions, risks of microbial adaptation and resistance, and where the proven unique bonding and durability performance has been demonstrated. This file contains the key chemical, analytical, manufacturing, application processes, leachate, biocompatibility, antimicrobial efficacy and genotoxicity data useful for our medical device customers to facilitate their use of our products and processes and to ease the efforts needed for review by the FDA.
■ Chemical Characterization
This includes all data on the specific chemistries, their structures, their physical and chemical properties and the preferred analytical procedures with sensitivity and precision limits. This includes data on the monomers and the reacted polymer. Analytical methods with all Good Laboratory Practice (GLP) information such as accuracy, sensitivity, reproducibility, and precision and bias are included. This will include credentials of operators, checks on equipment, checks on instrumentation and sources and checks on reagents.
This section contains all of our proprietary data on the scale up and Standard Operating Procedures (SOP) for manufacturing of the chemistries involved. It includes Confidential Statements of Formula and all quality control and quality assurance procedures for raw materials, active ingredients and inert ingredients.
The FDA has a tiered testing approach to defining risks associated with biocompatibility safety parameters. This part of the file contains biocompatibility test data on the Nano Safe Coatings technologies as applied to representative metal and plastic model substrates. The tests will be conducted on the model substrates based on ISO 10993 standards.
The FDA has a tiered testing approach to defining risks associated with genotoxicity safety parameters. This part of the file contains genotoxicity test data on the Nano Safe Coatings technologies as applied to representative metal and plastic model substrates.
■ Microbiological Data
Support Data and Hypothesis Rationale for the unique mode of action of the Nano Safe Coatings technologies. Microbiological performance/efficacy data using end use specific testing protocols and standard testing protocols for surface-active antimicrobials are in this part of the file. These include data on representative Gram (-) and Gram (+) bacteria, antibiotic resistant organisms, and those known to cause biofilms.
■ Application Process Data
The Nano Safe Coatings Technologies utilize proprietary application procedures that are most often customer specific but have common steps and parameters. These application data are in this part of the file and are linkable to what is used for any one specific medical device simplifying the FDA’s review. These data are linked to the toxicity, microbiological, and durability databases. This part of the file has the full range of application procedures any pre-preps of the treatment solutions and methods of application from spray (mist and fog), pad, exhaust, true electrostatic, sonication, UV curing, and wipe including all drying/curing variables. The details of this are very critical for all of the sample preparations for the chemical characterizations, efficacy testing, toxicological tests, leaching studies, as well as for customer trials where they will be submitting data on their products in triplicate production lot studies.
To gain access to the DMF, a Grant-of-Access Letter will be issued to eligible customers and will be product specific and be signed by a Board-appointed officer of the Nano Safe Coatings. Whether the granting of this letter is done for a fee will be decided on a customer-by-customer basis and will always be done under an NDA and with a development and/or a supply contract in place. During the course of submitting products, our customers will need to supply some data on predicate devices and products or devices they produce. The more information that links to our DMF and the methods used in our DMF, the easier it will be for them to get FDA acceptance. Some of the data will be based on their processing and the use and abuse in the end use. This could include tests such as: Cure Cycle, contamination during processing (QA, QC, and avoidance factors), damage from gamma or dry heat sterilization, leaching of components that might affect the treatment, in-vivo exposure factors such as high acidity of microbial contamination exposures, fragmentation failure, cyclic failure, iatrogenic damage risks, and other product and quality control data.
When a customer uses our DMF, where we give specific access, they will be required to show molecular exposure potentials linked directly to the analytical procedures and rationales in our DMF. They will need verifying data that could include: pyrogenicity, cytotoxicity, hemocompatibility, gas-chromatography of exhaustive solvent extractions, gel permeation studies, FTIR or GC of extracts, heavy metal analysis using induction plasma coupling, and trace volatiles per EPA 8260.