The FDA yesterday released its final recommendations for legal exemptions for customized medical devices that deviate from already-approved systems by being tailored to the special needs of up to 5 patients.
Examples of such devices might include implantable devices like artificial discs or surgical screws for very tall people or infants that are otherwise unavailable in the correct size.
The FDA released a draft version of the guidance last January and will continue to accept public comment on the new recommendations at www.regulations.gov to consider in any future revisions to the guidance.
The exemptions apply to FDA pre-market approval and mandatory performance standards under the Food, Drug & Cosmetic Act. Other FD&C requirements that still apply include those governing medical device reporting, labeling, corrections and removals, and registration and listing.
New concepts or procedures introduced in the document cover:
- Devices created or modified in order to comply with the order of an individual physician or dentist;
- The potential for multiple units of a device qualifying for the custom device exemption; and
- Annual FDA reporting requirements by the manufacturer about devices manufactured and distributed under section 520(b) of the FD&C Act.
The FDA provided clarity on the 5-device limit in instances where a physician requires an extra device for sizing concerns (the unused device it replaces must be destroyed or returned to the manufacturer); or for bilateral treatments, in which case 2 devices would be counted as 1.
The FDA noted that historically, practitioners and manufacturers have sought custom device exemptions for devices more properly considered under a "compassionate use" definition for treating patients who suffer from a serious condition for which no alternative treatment exists – the compassionate use designation was recently invoked in administering an experimental drug to 2 U.S. citizens who contracted the Ebola virus.
The agency added some devices deemed ineligible for custom devices status prior to passage in 2012 of the Food and Drug Administration Safety and Innovation Act would remain ineligible under the new provision, but may qualify for compassionate use.