FDA Guidances: Product Recalls, Device Clinical Data from ex-US studies, 510(k) Refusal to File Policies – Drug and Device Digest

CapturePublic Warning and Notification of Recalls

Recall: Removal of marketed product that considered to be in violation of FDA laws; Agency would initiate legal action. NOT the same as market withdrawal

Recall Determination:  FDA assessment FDA that ongoing or completed removal or correction of a marketed violative product constitutes a recall

Recall Classification: I, II, or III, assigned by FDA on basis of the health hazard

  • Class I: Could cause serious health problems or death
  • Class II: Might cause a temporary health problem
  • Class III: Unlikely to cause any adverse health reaction, violate FDA labeling or manufacturing laws

Public Warning:  Alert public that product being recalled presents a serious health hazard; for Class I recalls

Public Notification of Recalls: Weekly FDA Enforcement Report

FDA 101: Product Recalls



Acceptance of Clinical Data to Support Medical Device Applications and Submissions

FDA regulations on data acceptance from clinical investigations conducted outside US

  • Conform with good clinical practices (GCP)
  • Applies to clinical data submitted to support IDE, 510(k), De Novo, PMA, PDP, HDE

Conformity with GCP

  • Statements regarding conduct of clinical investigations
  • Special considerations for in vitro diagnostic (IVD) device investigations using leftover, de-identified biospecimens

Supporting Information, Waivers, Records



Refuse to Accept Policy for 510(k)

Minimum threshold of acceptability and acceptance for substantive review of 510(k)  

  • Submission is administratively complete, includes information necessary reach determination regarding substantial equivalence
  • Same intended use as predicate device
  • Same technological characteristics as predicate device – or- different technological characteristics
  • Appropriate clinical or scientific data to demonstrate safety and effectiveness
  • Does not raise different questions of safety and effectiveness than the predicate
  • Pre-Submission Interaction encouraged

Refuse to Accept Principles

  • Not based on substantive review of information
  • Justification for any alternative approach
  • Consideration of device-specific and cross-cutting guidances

Checklist provided


Image credit: FDA

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