Software Bill of Materials (SBOM) Validation Comparison Dataset

Background
The U.S. Food and Drug Administration (FDA) is responsible for protecting public health by ensuring the safety, efficacy, and security of various products including medical devices.

The Center for Devices and Radiological Health (CDRH) aims to provide timely access to safe and effective medical devices while facilitating innovation in regulatory science.

Recent legislation, the Food and Drug Omnibus Reform Act of 2022, mandates that manufacturers submit a Software Bill of Materials (SBOM) for certain medical devices to ensure cybersecurity compliance. This contract with MedCrypt, INC focuses on developing a validation comparison dataset for SBOMs to support these regulatory requirements.

Work Details
The contractor will perform the following tasks:
1. Kickoff Meeting to align on project objectives.
2. Dataset Tailoring and Integration which includes:
a. Creating a Test Dataset to validate initial findings;
b. Developing a Final Dataset that meets FDA requirements.
3. Implementing Encryption, Automated Push, and Decryption processes for data security.
4. Packaging Analysis Requests to facilitate data review and submission processes. Deliverables will include machine-readable formats of SBOMs that detail software components associated with medical devices.

Place of Performance
The work will be conducted at MedCrypt's facilities located at 125 S. Hwy 101, #101 Solana Beach, CA 92075.