The table above comes from the Federal Register, and it explains the classification scheme (including new product codes) for the new 510(k) exemptions for Class II devices. Clearly, these five exemptions do not have far-reaching implications. This update from the FDA will likely only be significant to our clients in the fields of assisted reproduction, rehabilitation and massaging devices, or osteochondral implants.
The exemptions were made pursuant to a final rule by the FDA, attached here: FDA Final Rule: Exemptions from PMN for Class II – July 2020. These exemptions are effective as of July 22, 2020. Under the 21st Century Cures Act, the FDA may exempt devices from 510(k) requirements if they decide a submission is not necessary to provide reasonable assurance of the safety and effectiveness of a Class II device.
Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.