What information must be included in a 510(k) premarket notification submission? Answer in under 100 words. Cite only eCFR (www.ecfr.gov) sources.

Details / How it works

Each premarket notification submission under § 807.87 must contain:

• (a) Device name (trade/proprietary and common/usual/classification name).
• (b) Establishment registration number of the submitter.
• (c) Device class under section 513 of the act and panel, or a statement of non-classification with basis.
• (d) Action taken to comply with performance standards under section 514.
• (e) Proposed labels, labeling, and advertisements describing intended use and directions; photographs or engineering drawings where applicable.
• (f) Statement and supporting data comparing the device to similar products in commercial distribution.
• (g) Supporting data for devices with significant changes/modifications or new indications affecting safety or effectiveness.
• (h) A 510(k) summary per § 807.92 or 510(k) statement per § 807.93.
• (i) Financial certification or disclosure per part 54.
• (j) For submissions supported by clinical data: statements of compliance with parts 50, 56, and 812 (U.S. studies), or § 812.28 / GCP (foreign studies).
• (k) For class III substantial-equivalence claims: a class III summary, class III certification per § 807.94, and citations.
• (l) Truthfulness and accuracy statement.
• (m) Any additional information requested by the Commissioner.

Exceptions & edge cases

• Clinical investigations not subject to IRB regulations may reference § 56.104 or § 56.105.
• Foreign clinical investigations not conducted per GCP under § 812.28(a) require a waiver request under § 812.28(c) or a brief statement of noncompliance with steps taken to ensure credible data.
• The class III summary information does not include data already submitted under section 519 of the act.
• If the Commissioner requests additional information, the submitter has 30 days to respond; otherwise the premarket notification is deemed withdrawn.