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Compliance In Focus
Posted by Brandy Chittester on Tue, Nov 20, 2012

5 Questions FDA Asks Regarding UDI Rule

Currently, the FDA is in the process of developing an implementation strategy and policy for5 Questions FDA Ask Regarding UDI Rule the proposed Unique Device Identification (UDI) Rule. While this has been in the works for quite some time, still more changes are being made and more questions are being raised concerning this rule.

FDA released an article regarding an amendment to the proposed rule. If signed into law, the proposed amendment would “require modification of the timeframe for implementation of the proposed rule's requirements as they apply to devices that are implantable, life-saving (life-supporting), or life-sustaining.”

In addition to this request, FDA also expanded on the custom device exemption criteria in the FD&C Act amended by FDASIA according to the press-release on Federal Register. Interestingly enough, in the news-release FDA also urges the public to respond to specific questions regarding the proposed exemption criteria for certain medical devices.

Device fit the “custom device exemption criteria” if they meet specific requirements of the FD&C Act, such as a device that is: Created or modified in order to comply with a physician or the special needs of a qualified person; For the purpose of treating a unique pathology or physiological condition (etc.).

FDA is particularly interested in receiving information from the public relating to:

  1. Input from patients, manufacturers, dentists, or physicians on where use of the custom device exemption is appropriate.
  2. Specific instances where manufacturers, dentists, or physicians have used, would have liked to use, or plan to use the custom device exemption for treatment of a sufficiently rare condition.
  3. Product areas other than orthopedic and dental devices where the custom device exemption may be useful.
  4. The type of information manufacturers intend to require a physician, dentist, or other qualified person to submit to them when ordering a custom device.
  5. How often a custom device is ordered due to unusual anatomical features of the individual physician/dentist, or due to a unique need in the physician's/dentist's practice not shared by health professionals of the same specialty

It seems like the UDI rule is a moving target. We’ve covered the progress of the proposed rule for quite some time. In fact, we have blogs on Industry urging changes to UDI and when the FDA first released the proposed rule.

How do you think these questions/answers will impact the medical device industry? Feel free to express your thoughts below.

Photo Credit: @boetter

Topics: UDI Rule, FD&C Act, Federal Register, FDA

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