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# Latest Federal Register Notices
- URL: https://www.fdaweb.com/latest-federal-register-notices-42/
- Published: 2021-06-06T12:00:00.000Z
- Updated: 2026-09-14T17:01:58.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5149138

**Some Software Functions Exempted from Device Definition**  
6/4/2021 *Federal Register* final rule: FDA is amending medical device classification regulations to exclude certain software functions from the definition of a device as mandated by the 21st Century Cures Act’s medical software provisions. The Cures Act amended the definition of a device in the FD&C Act to exclude certain software functions. FDA is taking this action so that its regulations conform to the medical software provisions in the Cures Act. Among the software functions excluded from the definition of a device by this provision are those intended to transfer, store, convert formats, or display clinical laboratory test or other device data, results, and findings and that do not interpret or analyze such clinical laboratory test or other device data, results, and findings. Because the provision only excludes certain software functions from the device definition, the regulatory status of device hardware remains unchanged. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-07860.pdf?ref=fdaweb.com).

**Latex Gloves Need 510(k); More Surveillance**  
*6/4/2021 Federal Register* notice: FDA is clarifiying that despite enforcement discretion efforts during the Covid-19 pandemic, Class 1 surgeon and patient examination gloves will continue to require premarket notification. Furthermore, because of the potential risks posed by gloves that have not undergone FDA’s premarket review, FDA intends to increase surveillance on the gloves. The agency says the increased surveillance could, for example, include a labeling review and a physical examination to assess for physical defects. Because most gloves are imported, FDA’s focus will be on products at the time of importation. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-04-16/pdf/2021-07759.pdf?ref=fdaweb.com).

**Workshop on Morphine Milligram Equivalents**  
6/3/2021 *Federal Register* notice: FDA has announced a 6/17-18 public workshop entitled “Morphine Milligram Equivalents: Current Applications and Knowledge Gaps, Research Opportunities, and Future Directions.” The workshop is intended to bring stakeholders together to discuss the scientific basis of morphine milligram equivalents (MMEs) with the goals of providing an understanding of the science and data underlying existing MME calculations for opioid analgesics, discussing the gaps in these data, and discussing future directions to refine and improve the scientific basis of MME applications. To view the notice, click [here](https://public-inspection.federalregister.gov/2021-07837.pdf?ref=fdaweb.com).

**Guide on Drug Supply Security Product Identifiers**  
6/2/2021*Federal Register* notice: FDA is making available a final guidance entitled *Product Identifiers Under the Drug Supply Chain Security Act: Questions and Answers*. The document is intended to address questions about product identifiers that are required to be affixed to, or imprinted on, packages and homogenous cases of certain drug products. It also clarifies FDA’s interpretation of the requirements, such as how they relate to linear barcode requirements. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2021-06-04/pdf/2021-11733.pdf?ref=fdaweb.com).