Risk Management

Off-label Drugs and Devices

Sample Language For Off-label Consent. Physicians are well-advised to obtain informed consent for off-label devices or drugs.

See OMIC’s sample consent language to incorporate into consent forms as needed.

Off-Label Sample Consent Language

See list of articles and forms about the use of off-label and unapproved drugs and devices below.

Medicolegal Implications of Using Off-label Drugs and Devices

Informed Consent and Elective  Procedures

Liability Issues Associated with PRK and the Excimer Laser

When FDA Leaves Doctors to Their Own Devices

Checklist for risk analysis of unapproved devices

Suggested Informed Consent Clauses for Documenting Off-Label PRK

Insuring Refractive Surgery:  Liability Risks

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