Abbreviated 510(k)
510(k) variant that relies on FDA guidance, special controls, or recognized consensus standards.
Definition
An Abbreviated 510(k) uses summary reports of compliance with relevant FDA guidance documents, special controls, or recognized consensus standards in lieu of submitting full underlying test data. It can shorten preparation and review when suitable standards exist. FDA can still ask for the underlying data, so complete test reports should be kept in the design history file.What this means in practice
Useful for well-understood device types where standards substantially cover safety and performance. Reviewers still expect summary information demonstrating conformance.Examples
- A manufacturer of a new sterile, single-use surgical glove might submit an Abbreviated 510(k) by demonstrating conformity to recognized consensus standards like ASTM D3577 for medical gloves.
- For a dental amalgam alloy, an Abbreviated 510(k) could involve providing summary data showing compliance with ISO 24234, Dentistry, Amalgam alloys.
- A blood glucose meter company might use an Abbreviated 510(k) by presenting a summary of compliance with ISO 15197 for in vitro diagnostic test systems for self-testing.
- •A common pitfall is the assumption that no testing data is required; instead, summary reports demonstrating conformance to recognized standards or special controls are necessary.
- •Failing to adequately cite or demonstrate compliance with all applicable sections of relevant guidance documents or standards can lead to delays.
- •Manufacturers sometimes incorrectly assume that an Abbreviated 510(k) is suitable for novel devices without clear predicate devices or recognized standards.
- •Submitting an Abbreviated 510(k) without a thorough understanding of the specific requirements for summary reports can result in a request for additional information or a refuse to accept decision.
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· Hand-selected related conceptsMore in Regulatory
· Same categoryTwo alternative disclosure mechanisms in a 510(k) submission, a Summary is public on FDA's website; a Statement promises to share Safety & Effectiveness info on request.
Formal mechanism to ask FDA whether a product is a device and, if so, its likely classification.
FDA voluntary program in which accredited testing labs perform standards-based testing accepted with reduced FDA scrutiny.
FDA framework for nonprescription drugs with approved additional conditions needed for appropriate self-selection or actual use when labeling alone is insufficient.
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Sources
3 sourcesSources support the definition or relevant regulatory context, not necessarily every claim on this page. Each is graded against our source-tier hierarchy so you can see what rests on binding law versus commentary.
- 1The Abbreviated 510(k) ProgramTier 2 VerifiedFDAfda.gov
- 2RAPS Regulatory FocusTier 4 VerifiedRAPSraps.org
- 3FDA - Medical DevicesTier 2 VerifiedFDAfda.gov
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