Know the boundaries
Not for: Radiofrequency microneedling, PRP, exosomes, drug delivery, or at-home treatment instructions.
Source-checked educational draft, version 1.0, September 20, 2026. Not reviewed or approved by an attorney or clinician. A qualified professional must adapt and approve it for the practice, jurisdiction, patient and actual service before use. A signature does not replace an informed discussion. Adult templates only; not a minor or proxy-consent workflow.
Inside the template
Five pages: practice preparation, patient discussion, two completion pages, and an implementation/source appendix. The PDF has fillable text fields; use the Word version to revise the language. 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
Proposed treatment
The clinician has explained the conventional microneedling device and planned treatment area. Small needles create punctures in the skin. The intended improvement and the device-specific patient information are recorded below.
Risks to discuss
Possible effects include redness, discomfort, dryness, peeling, bruising, bleeding and crusting. Infection, pigment changes and reactivation of cold sores are possible. Results vary and some adverse effects can persist. The clinician must explain risks specific to my skin and the device.
Limits of this consent
This document does not cover radiofrequency energy or introducing PRP, exosomes, medicines or other products into the skin. FDA-authorized uses are device-specific; authorization of a device is not approval of every combination treatment. RF microneedling has separate safety concerns and is excluded.
Details to complete before signing
- Patient name
- Practice / treating clinician
- Exact product or device and treatment area
- Treatment goal and anticipated benefit
- Labeling / patient information version supplied
- Patient-specific risks and relevant history reviewed
- Alternatives discussed, including no treatment
- Questions and answers / additional agreed limits
- Aftercare instructions and follow-up plan reference
- Practice urgent contact / after-hours route
- Patient signature and date / time
- Clinician signature and date / time
- Copy supplied: 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.