FDA Guidance IDE Device Medicare Coverage

The US FDA issued a draft guidance entitled: “FDA Categorization of Investigational Device Exemption (IDE) Devices to Assist the Centers for Medicare and Medicaid Services (CMS) with Coverage Decisions”. This draft defines criteria for determination of Class A or B. This is very important for companies where Medicare/Medicaide reimbursement is a factor. The key is wheter FDA considers a device expirmental (where safety and effectiveness is unknown per 42 CFR 405.201(b)) or investigational (where initial questions of safety and effectiveness have been resolved per 42 CFR 405.201(b).).

Remote Webmeeting Assessments

SoftwareCPR can provide remote offsite assessments to support virtual offices.  Our consultants can utilize webmeeting tools to walk your teams through assessments such as:

  • 62304 compliance
  • Regulatory submission pre-review
  • Software risk analysis
  • Cybersecurity process and validation
  • Overall ISO 14971 risk management
  • Overview of software regulation with John Murray

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