The FDA today published a list of Class I and Class II medical devices that it now considers exempt from premarket notification, in accordance with the 21st Century Cures Act.
Sponsors of these devices will no longer have to apply for 510(k) clearance from the FDA. The agency said this action, published today in the Federal Register, decreases the regulatory burden on the medtech industry and eliminates private costs and expenditures required to comply with certain federal regulations.
Sponsors of devices covered by exemption stand to save some money. User fees for devices covered by 510(k) regulations went up nearly 6% from fiscal year 2019 to FY2020, from 10,953 to $11,594.
Included in the exempt list are:
- Clinical chemistry test systems.
- Clinical laboratory instruments.
- Clinical toxicology test systems.
- Hematology and pathology devices.
- Immunology and microbiology devices.
- Ophthalmic devices.
- Radiology devices.
Devices now exempt from the 510(k) to determine their reasonable safety and effectiveness are still subject to other statutory and regulatory requirements, the agency said. The exemptions go into effect today.