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FDA Warning Letter Explorer
FDA warning letter · Medical Devices

Hologic, Inc.

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Failure to establish and maintain procedures to control the design of the device in order to ensure that specified design requirements are met, as required by 21 CFR 820.30(a). You did not implement your Design Control Procedures, including Design Control SOP0018 dated 01/31/2017, Product Development Procedure ENG0100 dated 03/19/2024 and User Needs and Intended Use Statement Procedure ENG-0100-02 dated 04/21/2022. Specifically:

Passage 2

Failure to submit a report to FDA no later than 30 calendar days after the day that the firm received or otherwise became aware of information, from any source, that reasonably suggests that a device that the firm markets may have caused or contributed to a death or serious injury, as required by 21 CFR 803.50(a)(1).

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 7
  • 21 CFR 803.50(a)(1)
  • 21 CFR 803.3
  • 21 CFR 803
  • 21 CFR 806
  • 21 CFR 806.10
  • 21 CFR 806.2(j)
  • 21 CFR 820.30(a)
  • 21 CFR 820.30(c)
  • 21 CFR 820.30(f)
  • 21 CFR 820.30(g)
  • 21 CFR 820.30(h)
  • 21 CFR 820.100(a)(1)