GroundRules
Browse Federal regulations
Read the original sections, or search by topic.
- 21 CFR 878.4022 · Hydrogel wound dressing and burn dressing.
- 21 CFR 878.4025 · Silicone sheeting.
- 21 CFR 878.4040 · Surgical apparel.
- 21 CFR 878.4100 · Organ bag.
- 21 CFR 878.4160 · Surgical camera and accessories.
- 21 CFR 878.4165 · Wound autofluorescence imaging device.
- 21 CFR 878.4200 · Introduction/drainage catheter and accessories.
- 21 CFR 878.4300 · Implantable clip.
- 21 CFR 878.4320 · Removable skin clip.
- 21 CFR 878.4340 · Contact cooling system for aesthetic use.
- 21 CFR 878.4350 · Cryosurgical unit and accessories.
- 21 CFR 878.4360 · Scalp cooling system to reduce the likelihood of chemotherapy-induced alopecia.
- 21 CFR 878.4370 · Surgical drape and drape accessories.
- 21 CFR 878.4371 · Irrigating wound retractor device.
- 21 CFR 878.4380 · Drape adhesive.
- 21 CFR 878.4400 · Electrosurgical cutting and coagulation device and accessories.
- 21 CFR 878.4405 · Focused ultrasound system for non-thermal, mechanical tissue ablation.
- 21 CFR 878.4410 · Low energy ultrasound wound cleaner.
- 21 CFR 878.4420 · Electrosurgical device for over-the-counter aesthetic use.
- 21 CFR 878.4425 · Skin patch for treatment of hyperhidrosis.
- 21 CFR 878.4430 · Microneedling device for aesthetic use.
- 21 CFR 878.4440 · Eye pad.
- 21 CFR 878.4450 · Nonabsorbable gauze for internal use.
- 21 CFR 878.4452 · Nonabsorbable expandable hemostatic sponge for temporary internal use.
- 21 CFR 878.4454 · Non-absorbable, hemostatic gauze for temporary internal use.
- 21 CFR 878.4456 · Hemostatic device for intraluminal gastrointestinal use.
- 21 CFR 878.4460 · Non-powdered surgeon's glove.
- 21 CFR 878.4470 · Surgeon's gloving cream.
- 21 CFR 878.4490 · Absorbable hemostatic agent and dressing.
- 21 CFR 878.4493 · Absorbable poly(glycolide/l-lactide) surgical suture.
- 21 CFR 878.4494 · Absorbable poly(hydroxybutyrate) surgical suture produced by recombinant DNA technology.
- 21 CFR 878.4495 · Stainless steel suture.
- 21 CFR 878.4520 · Polytetrafluoroethylene injectable.
- 21 CFR 878.4550 · Autofluorescence detection device for general surgery and dermatological use.
- 21 CFR 878.4580 · Surgical lamp.
- 21 CFR 878.4590 · Focused ultrasound stimulator system for aesthetic use.
- 21 CFR 878.4630 · Ultraviolet lamp for dermatologic disorders.
- 21 CFR 878.4635 · Sunlamp products and ultraviolet lamps intended for use in sunlamp products.
- 21 CFR 878.4660 · Skin marker.
- 21 CFR 878.4670 · Internal tissue marker.
- 21 CFR 878.4675 · Breast implant suction retrieval system.
- 21 CFR 878.4680 · Nonpowered, single patient, portable suction apparatus.
- 21 CFR 878.4683 · Non-Powered suction apparatus device intended for negative pressure wound therapy.
- 21 CFR 878.4685 · Extracorporeal shock wave device for treatment of chronic wounds.
- 21 CFR 878.4700 · Surgical microscope and accessories.
- 21 CFR 878.4730 · Surgical skin degreaser or adhesive tape solvent.
- 21 CFR 878.4740 · Surgical stapler.
- 21 CFR 878.4750 · Implantable staple.
- 21 CFR 878.4755 · Absorbable lung biopsy plug.
- 21 CFR 878.4760 · Removable skin staple.
- 21 CFR 878.4780 · Powered suction pump.
- 21 CFR 878.4783 · Negative pressure wound therapy device for reduction of wound complications.
- 21 CFR 878.4790 · Powered surgical instrument for improvement in the appearance of cellulite.
- 21 CFR 878.4800 · Manual surgical instrument for general use.
- 21 CFR 878.4805 · Manual percutaneous surgical set assembled in the abdomen.
- 21 CFR 878.4810 · Laser surgical instrument for use in general and plastic surgery and in dermatology.
- 21 CFR 878.4815 · Magnetic surgical instrument system.
- 21 CFR 878.4820 · Surgical instrument motors and accessories/attachments.
- 21 CFR 878.4825 · General laparoscopic power morcellation containment system.
- 21 CFR 878.4830 · Absorbable surgical gut suture.
- 21 CFR 878.4840 · Absorbable polydioxanone surgical suture.
- 21 CFR 878.4850 · Blood lancets.
- 21 CFR 878.4860 · Light based energy source device for topical application.
- 21 CFR 878.4880 · Phototherapy device for reducing the appearance of acute post-surgical incisions.
- 21 CFR 878.4930 · Suture retention device.
- 21 CFR 878.4950 · Manual operating table and accessories and manual operating chair and accessories.
- 21 CFR 878.4960 · Operating tables and accessories and operating chairs and accessories.
- 21 CFR 878.4961 · Mountable electromechanical surgical system for transluminal approaches.
- 21 CFR 878.5000 · Nonabsorbable poly(ethylene terephthalate) surgical suture.
- 21 CFR 878.5010 · Nonabsorbable polypropylene surgical suture.
- 21 CFR 878.5020 · Nonabsorbable polyamide surgical suture.
- 21 CFR 878.5030 · Natural nonabsorbable silk surgical suture.
- 21 CFR 878.5035 · Nonabsorbable expanded polytetrafluoroethylene surgical suture.
- 21 CFR 878.5040 · Suction lipoplasty system.
- 21 CFR 878.5050 · Surgical smoke precipitator.
- 21 CFR 878.5070 · Air-handling apparatus for a surgical operating room.
- 21 CFR 878.5080 · Air-handling apparatus accessory.
- 21 CFR 878.5350 · Needle-type epilator.
- 21 CFR 878.5360 · Tweezer-type epilator.
- 21 CFR 878.5400 · Low level laser system for aesthetic use
- 21 CFR 878.5650 · Topical oxygen chamber for extremities.
- 21 CFR 878.5900 · Nonpneumatic tourniquet.
- 21 CFR 878.5910 · Pneumatic tourniquet.
- 21 CFR 880.1 · Scope.
- 21 CFR 880.3 · Effective dates of requirement for premarket approval.
- 21 CFR 880.9 · Limitations of exemptions from section 510(k) of the Federal Food, Drug, and Cosmetic Act (the act).
- 21 CFR 880.2200 · Liquid crystal forehead temperature strip.
- 21 CFR 880.2400 · Bed-patient monitor.
- 21 CFR 880.2420 · Electronic monitor for gravity flow infusion systems.
- 21 CFR 880.2460 · Electrically powered spinal fluid pressure monitor.
- 21 CFR 880.2500 · Spinal fluid manometer.
- 21 CFR 880.2700 · Stand-on patient scale.
- 21 CFR 880.2720 · Patient scale.
- 21 CFR 880.2740 · Surgical sponge scale.
- 21 CFR 880.2750 · Image processing device for estimation of external blood loss.
- 21 CFR 880.2800 · Sterilization process indicator.
- 21 CFR 880.2900 · Clinical color change thermometer.
- 21 CFR 880.2910 · Clinical electronic thermometer.
- 21 CFR 880.2920 · Clinical mercury thermometer.
- 21 CFR 880.2930 · Apgar timer.