Agency IQ

SEPTEMBER 29, 2023

June 2023 Sunlamp Products; Amendment to the Performance Standard (Final Rule) FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

0910-AI78 June 2023 May 2023 Final Rule Stage Sunlamp Products; Amendment to the Performance Standard FDA is updating the performance standard for sunlamp products and ultraviolet lamps intended for use in these products to improve safety, reflect new scientific information, and work towards harmonization with international standards.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

OCTOBER 27, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

FDA 40

FDA Science Regulations Production 40

Agency IQ

DECEMBER 1, 2023

The revisions will update the existing requirements with the specifications of an international consensus standard for medical device manufacturers, ISO 13485:2016. to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug.

FDA 40

FDA Science Regulations Production 40