This blog explains how many sections of a 510k submission have a direct correlation to Design Controls.
If you are developing a medical device for the U.S. market, there is a decent chance you will need to prepare a 510(k) submission. Of course, there are some devices that do not require a submission, and also those that require a more involved PMA. But, if your medical device falls into the FDA Class II category, a 510(k) submission is required for market clearance.
Regardless of the device classification, Design Controls are a critical component to medical device product development. Design Controls demonstrate you have designed and developed a medical device that meets user needs, is safe and effective.
The relationship between Design Controls and regulatory submissions is strong. Design Controls are needed to ensure that you have the data to support your submission to the FDA for pre-market notification. A traditional FDA 510(k) submission contains 20 sections, and many of those sections are linked directly to Design Controls.
Indications for Use
The indications for use statement in a 510k submission describes the clinical application of a medical device. Before starting a medical device product development project, there must be a clinical need defined. This clinical need evolves into indications for use and results in User Needs. User needs describe what the end-user (including patient) expect the medical device to do. User needs are the pre-cursor to a medical device’s Design Inputs.
Declarations of Conformity
A 510k submission includes making declarations of conformity to any industry standard used during medical device product development. Some common standards include ISO 10993 (for biocompatability) and IEC 60601 (for electrical safety). Your medical device may require that you demonstrate compliance to other industry standards.
Any standards you reference as part of your medical device project have a direct relationship to Design Controls. Specifically, standards often specify requirements, acceptance criteria, and test methods. The contents of each standard must be translated directly into Design Inputs for your medical device or you must provide a justification of why the specific clause is not applicable. Additionally, declaring conformity to a standard means you will need to prove you meet the criteria within the standard. This is done via Design Verification activities.
The entire premise of a 510k submission is to demonstrate that your medical device is substantially equivalent to another medical device which has received FDA 510k market clearance. Doing so often requires head to head testing and other activities to demonstrate your product is equivalent to a predicate device. Activities to support substantial equivalence are often captured as Design Verification activities.
The proposed labeling is included with a 510k submission. Labeling includes the labels applied directly to the product and packaging, as well as instructions for use and user manuals. Labeling is part of the Design Outputs captured during product development. Labeling also tells the user about residual risks that design controls were not able to completely eliminate.
Sterilization & Shelf Life
If your medical device requires sterilization, you must provide details regarding sterilization methods and specifications with your 510k submission. Sterilization methods and specifications are Design Outputs. Expect to also provide a sterilization validation protocol, as well as results, with your 510k. These are Design Verification activities.
The same is true with shelf life activities. Shelf life definitions are defined as Design Outputs, usually via product labeling. These labeling claims of shelf life must subsequently be verified during design verification.
If your product has contact with a patient and/or end-user, you need to demonstrate biocompatibility within your 510(k) submission. Biocompatibility requirements must be defined as Design Inputs, and the Design Verification data must include evidence of meeting these requirements.
If your medical device includes software, there is quite a bit of documentation you are expected to provide as part of a 510k submission. Things like Software Requirements Specifications (part of Design Inputs), Software Design Specifications (part of Design Outputs), and Software Verification Test Plan & Results (part of Design Verification). Depending upon the level of risk, risk management documentation may also be required for devices involving software.
If your medical device includes electronics, you need to demonstrate electromagnetic compatibility and overall electrical safety within the 510k. This involves IEC 60601 and all the applicable parts of this standard to your product. Electrical requirements should be specified as Design Inputs. All the test results are Design Verification activities.
All bench, animal, and clinical performance testing must be provided with your 510k submission. Required performance testing is specified for some device classifications with documented Special Controls Guidance Documents, while other device classifications require only that you provide performance testing demonstrating that the device in your submission is equivalent to the predicate device. This performance testing must be specified as verification and validation testing in your Design Plan.
Jon Speer is a medical device veteran with more than 16 years experience. Jon specializes in helping medical device start-up companies with design project management. His experience with start-ups gave him the idea to develop a software solution to help companies document Design Controls. If you are interested in learning more about the software solution, greenlight.guru, you can find him on Google+, Twitter, and LinkedIn.