510k Exemption for Unclassified Medical Devices in Selected Product Categories
This guidance outlines FDA's intention to exempt specific unclassified medical devices from premarket notification (510(k)) requirements while maintaining other regulatory requirements such as registration, listing, labeling, quality system, and MDR requirements. The guidance excludes combination products and single-entity products containing antimicrobial agents.
Recommended Actions
- Review product portfolio to identify if any products fall under the listed product codes for exemption
- Maintain compliance with all other regulatory requirements despite 510(k) exemption
- Ensure quality system documentation reflects the exempt status while maintaining other controls
- Update regulatory strategy documentation to reflect the new exempt status of applicable devices
- Continue monitoring FDA communications for final rule publication regarding these exemptions
- Verify products are not combination products or contain antimicrobial agents before applying exemption
- Maintain registration and listing requirements for exempt devices
- Ensure ongoing compliance with MDR requirements and quality system regulation
Key Considerations
Labelling
- Must comply with 21 CFR part 801 labeling requirements
Safety
- Must comply with Medical Device Reporting requirements (21 CFR part 803)
- Must comply with Quality System regulation (21 CFR part 820)
Other considerations
- Registration and listing requirements (21 CFR part 807) must be maintained
- Specific product codes are identified for exemption in the following categories:
- Least Burdensome Principles for Medical Device Regulation
- Refuse to Accept Policy for 510k Submissions: Minimum Threshold Requirements for Administrative and Technical Review
- Content and Decision-Making Process for 510k Submissions: Determining Substantial Equivalence
- Medical Device Reporting (MDR) Requirements and Procedures for Manufacturers
Related references and norms
- 21 CFR 807: Establishment Registration And Device Listing For Manufacturers And Initial Importers Of Devices
- 21 CFR 801: Labeling
- 21 CFR 820: Quality System Regulation
- 21 CFR 803: Medical Device Reporting
Original guidance
- 510k Exemption for Unclassified Medical Devices in Selected Product Categories
- HTML / PDF
- Issue date: 2019-02-08
- Last changed date: 2019-06-14
- Status: FINAL
- Official FDA topics: Nose & Throat, Ophthalmic, Physical Medicine, Medical Devices, Obstetrical & Gynecological, Cardiovascular, Gastroenterology-Urology, General & Plastic Surgery, Anesthesiology, 510(k), Premarket, Ear, General Hospital & Personal Use, Orthopedic, Dental, Neurological
- ReguVirta summary file ID: 90e101e4655c3afcb30faec0b9685312
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