Medical device manufacturers need to say what's in their products

The FDA wants medical device manufacturers to package their products with a list of their hardware and software components, according to new draft guidance on medical device cybersecurity.The "cybersecurity bill of materials," as the FDA is calling it, would help end users keep a closer eye on the security of their medical devices, making sure there are proper safeguards in place to keep the devices functioning even if there are vulnerabilities."A cybersecurity bill of materials can be a critical element in identifying assets, threats and liabilities," the FDA said.The agency foreshadowed the requirement for a bill of materials in its Medical Device Safety Action Plan, released in April 2018.