Know the boundaries
Not for: Radiofrequency microneedling, PRP, exosomes, drug delivery, or at-home treatment instructions.
Source-checked template, version 2.0, September 21, 2026. Practice review and adaptation are required before use. No independent clinician or attorney approval is claimed. Adult patient self-consent only; use a separately reviewed process for minors or representatives.
Inside the template
Two clean, unbranded patient-facing pages: the relevant discussion, specific choices and completion fields, and the patient decision with signatures. The PDF includes fillable fields and selection controls where applicable. Use the Word version to adapt the language. Sources and practice guidance stay on this page. Typed fields are not a verified electronic-signature service.
Actual sample page · Open to enlarge · Full editable files available below
Prepare your practice version
- Check device labeling for the actual area, indication and patient eligibility.
- Review relevant skin history, medicines and individual risk factors.
- Discuss infection control and use of a new needle cartridge for each session.
- Explain expected recovery, sun/skin-care instructions and the practice contact route.
Public text preview
Language for the conversation
Skin effects
Redness, discomfort, tightness, dryness, peeling, itching, bruising, bleeding or crusting can occur. Recovery differs between patients; the skin is not guaranteed to heal within a fixed number of hours.
Additional complications
Infection, recurrence of cold sores, changes in skin color, marks or scarring, and irritation from products applied afterward are possible. Some adverse effects may persist. Results may be less than expected.
Individual and device factors
Skin characteristics, existing conditions, medicines, treatment area and device influence risk. A new needle cartridge is needed for each patient and each treatment session. This form is not a substitute for the device instructions.
Details to complete before signing
- Practice name
- Visit / discussion date
- Patient full name
- Date of birth
- Treating clinician
- Treatment date
- Exact product / device, planned treatment areas and intended benefit
- Patient labeling / instructions reviewed (version)
- Proposed use: labeled / off-label (explain)
- Any off-label use and its reason, uncertainties and alternatives discussed
- Relevant history, medicines, allergies and patient-specific risks / plan
- Alternatives discussed and patient questions / answers
- Written aftercare / patient information supplied
- Follow-up plan
- Urgent practice contact
- After-hours contact / instructions
- Patient signature
- Date / time
- Clinician / practice representative name
- Signature / date
- Interpreter name / ID if used
- Language
- Copy of completed consent provided by
- Date / method
Common questions
Does this cover RF microneedling?
No. RF adds an energy-based treatment component. FDA has published a separate safety communication; use a separately evaluated device-specific consent.
Can a clinic add PRP to this form?
Do not just add a checkbox. Combination treatments require their own evidence, regulatory and clinical review and a revised informed discussion.