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Dec 20 2019

New FDA guidance on alternate approaches in premarket notification for Class II medical devices

By Alice Li, MD, MSc, RAC (CAN), Regulatory Scientist, Cato Research

FDA issued “The Abbreviated 510(k) Program – Guidance for Industry and Food and Drug Administration Staff” on 13 September 2019. The content of this guidance supersedes the content from 1998 guidance “The New 510(k) Paradigm – Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications”.

Instead of the traditional 510(k), manufacturers may choose an alternative approach: to submit an abbreviated 510(k) to demonstrate substantial equivalence in premarket notification for class II medical devices, relying on one or more of the following:

  • FDA guidance document(s)

The use of guidance documents may facilitate the review through a reliance on a summary report that summarize the device description, the manufacturer’s device design, risk management, and a description of test methods used to address performance characteristics as recommended in relevant guidance document(s). The report should include information regarding any deviations or alternative methods used to demonstrate substantial equivalence that are not described in the guidance.

  • Special controls

The use of special control may also facilitate the review through reliance on a summary report that describes how a special control has been used to address a special risk or issue. Special controls are defined in section 513(a)(1)(B) of the FD&C Act as those controls, such as performance standards, postmarketing surveillance, patient registries, development and dissemination of guidelines, recommendations, and other appropriate actions that provide reasonable assurance of device’s safety and effectiveness.

  • Voluntary consensus standards

Manufacturers submitting an abbreviated 510(k) that relies on general use of a voluntary consensus standard should include a summary report describing the basis of such use along with the underlying information or data that supports how the standard was used.

The guidances “Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices” and “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in CBER” should be consulted.

Appendix A of the September 2019 guidance should be carefully referenced along with two other FDA guidances: “Refuse to Accept Policy for 510(K)s” and “Format for Traditional and Abbreviated 510(K)s”.

FDA believes that its review of abbreviated 510(k)s may be more efficient than that of traditional 510(k) submissions allowing for more efficient use of FDA’s review resources. However, FDA still intends to review abbreviated 510(k)s within the 90 days specified for 510(k) applications in the 2017 Medical Device User Fee Amendments, which is the same as the review period for a traditional 510(k).