The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released four final guidances in an effort to improve the efficiency of its 510(k) marketing authorization pathway.
- Special 510(k) Program
- Abbreviated 510(k) Program
- Format for Traditional and Abbreviated 510(k)s
- Refuse to Accept Policy for 510(k)s
The 510(k) program, through which authorizations for the majority of premarket devices are made is used by devices that are considerably identical to a device already available on the market. In an effort to modernize the 510(k) pathway, the combined documents are intended to provide clarity in order to promote faster access to new medical technologies while conserving resources for both the industry and FDA without having to adjust the statutory criteria for substantial equivalence.
Special 510(k)
Established in 1998, the Special 510(k) program offers an optional pathway for manufacturers and companies who want to make modifications to their own marketed devices. The finalized document provides clarity and transparency to describe when a Special 510(k) is appropriate, the content requirements and the basis for substantial equivalence (SE).
According to CDRH, the program was previously, “limited to review of changes that did not affect the device’s intended use nor alter the device’s fundamental scientific technology.” Now, the focus has shifted to determining if the method for evaluating change is well-established, and whether the results can be reviewed in a summary or risk-analysis format sufficiently. Appendix B of the final guidance names examples of changes that can be submitted as a Special 510(k), including certain design and labeling changes and changes to the indications for use. Five additional examples that were not included in the draft version of the guidance were listed as well.
Abbreviated 510(k)
The Abbreviated 510(k) is for device manufacturers to pursue when the 510(k) submission relies on FDA guidance documents or special controls. It is an alternative approach centered on efficient submission preparation and review by the FDA. To facilitate reviews, summary reports that describe and summarize relevant guidance documents may be used.
Summary reports summarize:
- device description
- the manufacturer’s device design requirements
- risk management information
- a description of test methods used to address performance characteristics
Format for Traditional and Abbreviated 510(k)s
This 21-page guidance provides a framework for how to format a traditional or abbreviated premarket notification 510(k) submission. The guidance supersedes a previous version released in 2005 and has been updated to align with changes made to the Special 510(k) Program.
The updated information included regards:
- animal and clinical performance testing
- proposed labeling
- Biocompatibility
- Software
Refuse to Accept Policy for 510(k)s
The 103-page guidance on the 510(k) Refuse to Accept (RTA) policy explains the procedures and criteria that CDRH will use to assess whether a 510(k) submission can be accepted for substantive review. Additionally, the finalized document provides clarity regarding the necessary contents of a complete 510(k) submission in its appendices. An early review of criteria is included so that the agency can inform the submitter within 15 calendar days after receipt of submission if it is administratively complete, or if there are missing elements.
How RegDesk Can Help
RegDesk’s platform provides medical device manufacturers with the latest updates on the most important regulations regarding the 510(k) program. With our service, medical device companies have access to the most recent amendments and requirements implemented to maintain compliance. Along with the FDA, RegDesk also provides information for over 100 markets worldwide to help medical device and pharmaceutical companies expand internationally.
The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) released four final guidances in an effort to improve the efficiency of its 510(k) marketing authorization pathway.
- Special 510(k) Program
- Abbreviated 510(k) Program
- Format for Traditional and Abbreviated 510(k)s
- Refuse to Accept Policy for 510(k)s
The 510(k) program, through which authorizations for the majority of premarket devices are made is used by devices that are considerably identical to a device already available on the market. In an effort to modernize the 510(k) pathway, the combined documents are intended to provide clarity in order to promote faster access to new medical technologies while conserving resources for both the industry and FDA without having to adjust the statutory criteria for substantial equivalence.
Special 510(k)
Established in 1998, the Special 510(k) program offers an optional pathway for manufacturers and companies who want to make modifications to their own marketed devices. The finalized document provides clarity and transparency to describe when a Special 510(k) is appropriate, the content requirements and the basis for substantial equivalence (SE).
According to CDRH, the program was previously, “limited to review of changes that did not affect the device’s intended use nor alter the device’s fundamental scientific technology.” Now, the focus has shifted to determining if the method for evaluating change is well-established, and whether the results can be reviewed in a summary or risk-analysis format sufficiently. Appendix B of the final guidance names examples of changes that can be submitted as a Special 510(k), including certain design and labeling changes and changes to the indications for use. Five additional examples that were not included in the draft version of the guidance were listed as well.
Abbreviated 510(k)
The Abbreviated 510(k) is for device manufacturers to pursue when the 510(k) submission relies on FDA guidance documents or special controls. It is an alternative approach centered on efficient submission preparation and review by the FDA. To facilitate reviews, summary reports that describe and summarize relevant guidance documents may be used.
Summary reports summarize:
- device description
- the manufacturer’s device design requirements
- risk management information
- a description of test methods used to address performance characteristics
Format for Traditional and Abbreviated 510(k)s
This 21-page guidance provides a framework for how to format a traditional or abbreviated premarket notification 510(k) submission. The guidance supersedes a previous version released in 2005 and has been updated to align with changes made to the Special 510(k) Program.
The updated information included regards:
- animal and clinical performance testing
- proposed labeling
- Biocompatibility
- Software
Refuse to Accept Policy for 510(k)s
The 103-page guidance on the 510(k) Refuse to Accept (RTA) policy explains the procedures and criteria that CDRH will use to assess whether a 510(k) submission can be accepted for substantive review. Additionally, the finalized document provides clarity regarding the necessary contents of a complete 510(k) submission in its appendices. An early review of criteria is included so that the agency can inform the submitter within 15 calendar days after receipt of submission if it is administratively complete, or if there are missing elements.
How RegDesk Can Help
RegDesk’s platform provides medical device manufacturers with the latest updates on the most important regulations regarding the 510(k) program. With our service, medical device companies have access to the most recent amendments and requirements implemented to maintain compliance. Along with the FDA, RegDesk also provides information for over 100 markets worldwide to help medical device and pharmaceutical companies expand internationally.
