WebJan 17, 2024 · The information on this page is current as of Jan 17, 2024. For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR). § 117.1 - Applicability and status. § 117.3 - Definitions. § 117.4 - Qualifications of individuals who manufacture, process, pack, or hold food. § 117.5 - Exemptions. WebApr 12, 2024 · Office of Communication and Education. Center for Devices and Radiological Health. Food and Drug Administration. 10903 New Hampshire …
CDRH Proposed Guidances for Fiscal Year 2024 (FY2024)
WebToday, CDRH is announcing a Radiation Sterilization Master File Pilot Program to help companies advance alternative and innovative ways to sterilize approved medical devices, including changing radiation sources, in a least burdensome regulatory approach. The pilot program is voluntary and intends to allow companies that sterilize single-use ... WebMedical device software continues to be among the top priorities for CDRH guidance in 2024, beginning with a final Guidance for clinical decision support software. The A-list also includes plans to issue new draft Guidance Documents related to computer software assurance for production and quality system software, medical device cybersecurity ... flambout
CFR - Code of Federal Regulations Title 21 - Food and Drug Administration
WebTitle 21. Displaying title 21, up to date as of 3/30/2024. Title 21 was last amended 3/30/2024. Manufacturer's obligation to repair, replace, or refund cost of electronic … WebThe CDRH goal is to protect the public from hazardous and unnecessary exposure to radiation from electronic products. For most electronic products, safety regulation is divided between CDRH and state regulatory agencies. CDRH regulates the manufacture of the products, and the states regulate the use of the products. WebPlease note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. ... Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further ... can parrots be pets