New Procedure for Variations in Medical Device CPR

The Circular applies specifically to all entities within the medical device industry.
It covers all variations, amendments, or changes made to the CPR issued by the Center for Device Regulation, Radiation Health, and Research (CDRRHR).

The application for variation of medical device product registration follows guidelines in FDA Circular No. 2016-010 but introduces new procedures under CDRRHR's Licensing and Registration Division.
Only one variation application per transaction is permitted irrespective of the number of CPRs held by the applicant.
Acceptable variations include:
- Change of legal manufacturer, exporter, and manufacturer if the name and address remain consistent across all CPRs.
- Change of importer and distributor.
- Change of location/address of importer and distributor.
- Change of manufacturer’s address.
- Change or addition of sterilization sites.
- Change of label design.
- Change of Instruction for Use (IFU).
- Other changes uniform across all CPRs.
Fees and charges are computed based on the number of CPRs affected by the amendment.
The applicant must submit a comprehensive list of all CPRs to be amended in both PDF and Word formats, including exact product descriptions and registration numbers.
Notification of approval of changes will be provided via letter.
These procedures apply to all variation applications received from July 22, 2016, onward.

All approved changes will be incorporated into the CPR during the product registration renewal.
Companies may request re-issuance of the CPR to reflect changes immediately, subject to payment of a re-issuance fee.

Any prior issuances conflicting with this Circular are repealed, rescinded, or modified accordingly.

If any provision or its application is declared invalid, the rest of the Circular’s provisions will remain effective and enforceable.

The Circular becomes effective fifteen (15) days after approval, ensuring timely implementation of the new procedures.