The FDA recently issued guidance on its intent to exempt five further categories of medical devices, that were until now unclassified, from premarket notification (510(k)) requirements.
Why does this matter for early-stage medical device companies?
It matters because demonstrating knowledge of the regulatory pathway you need to take to get your medical device to market convinces grant reviewers and investors that you know what you’re doing (this is a good thing).
When you draft SBIR/STTR submissions, knowing which path to marking authorization you’re taking means you can draft a realistic commercialization plan, accurately forecasting future timelines and costs. This demonstrates your understanding of your medical device’s path to commercialization, a necessary tool for you to convince reviewers that you can make it happen.
The updated list of exempt categories now includes:
- Ear, Nose, and Throat Devices
- Protector, Hearing (Insert)
- Protector, Hearing (Circumaural)
- Aids, Speech Training for the Hearing Impaired (AC-Powered and
- Patient-Contact)
- Aids, Speech Training for the Hearing Impaired (Battery-Operated or Non-Patient)
- Gastroenterology-Urology Devices
- Cushion, Hemorrhoid
- General and Plastic Surgical Devices
- Pad, Alcohol, Device Disinfectant
- Prosthesis, Nail
- Obstetrical and Gynecological Devices
- Device, Fertility Diagnostic, Proceptive
- Physical Medicine Devices
- Device, Sensing, Optical Contour
- Monitor, Spine Curvature
- Neurological Devices
- Device, Acupressure
- Toxicology Devices
- Strip, Test Isoniazid
- Ophthalmic Devices
- Cup, Eye
Note that these devices are still obligated to meet other regulatory requirements, including registration and listing (21 CFR part 807); labeling (21 CFR part 801); good manufacturing practice requirements (21 CFR part 820); and Medical Device Reporting (21 CFR part 803).
To view the guidance directly from the FDA, see here.
