FDA Device Accessories Classification Guidance

Today the FDA is announcing the availability of the updated final guidance, “Medical Device Accessories – Describing Accessories and Classification Pathways”. This guidance was updated and replaces the Jan 2017 version to include new mechanisms to request (1) a different classification for an existing accessory type (i.e., accessories already on the market), and (2) for new accessory types (i.e., accessories that have not been previously classified under the Federal Food, Drug, and Cosmetic Act (FD&C Act), cleared for marketing under a 510(k) submission, or approved in a PMA), as described in section 513(f)(6) of the FD&C Act.  SoftwareCPR® can provide expert Accessory, de novo, pre-sub, or 513(g) classification consulting services. If you are not already a paid subscription consider subscribing to receive all of our bulletins, newsletters, and access to education materials on our website including some Q&A with our experts.

FDA Website (http://goo.gl/FoP3Gq)

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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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