Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact | Site Map

FDA Update - FDA Finalizes the Regulations for the Reuse of SUDs (Single Use Disposal Devices)

The FDA has been actively engaged in reuse issues of medical devices labeled "Single Use Disposable." The FDA felt that they had to take action to protect the health of the public by assuring that the practice of reprocessing and reusing single-use disposable (SUDs) is safe and effective and based on good science.

The public expects and the law requires all medical devices to be safe, effective and manufactured in accordance with good manufacturing practices (GMPs).

The regulation concerning the Reuse of SUD is now in effect. This regulation is all encompassing for such companies and operations, including establishment registration, device listing, 510(k) or PMA submissions and GMP compliance including Design Control where necessary. These operations will also be required to submit MDRs in accordance with the regulatory requirements.

The FDA has outlined their enforcement requirements per facility. For third party reprocessors, the FDA is now requiring that the non-premarket requirements such as registration, listing, MDR, tracking (if applicable), correction and removals, quality system and labeling are in effect. The FDA has given the industry an 18 month time frame to get in the appropriate 510(k) or PMA in six month increments with PMAs required in 6 months, Class II device 510(k)s due in 12 months and Class I non-exempt device 510(k)s due in 18 months.

For Hospital Reprocessors the FDA is not actively enforcing the non-premarket requirements for these operations for the next 12 months. 12 months after the final rule the FDA will expect these companies to comply with these regulations. The 510(k) and PMA requirements are the same for these operations.

For more information on these regulations and requirements visit the FDA website at www.FDA.gov or contact mdi's office for a copy of the guidelines.

Home  | About mdi |  Services  | Industries | News & Information | Partners | Contact| Site Map