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)

What’s New

FDA:  Exemptions, Variances, and Alternate Forms of Adverse Event Reporting for Medical Devices

Manufacturers, importers, and user facilities can request an exemption or variance from any or all of the medical device reporting requirements in 21 CFR Part 803.  Read more:  https://www.fda.gov/medical-devices/medical-device-reporting-mdr-how-report-medical-device-problems/exemptions-variances-and-alternate-forms-adverse-event-reporting-medical-devices

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