federal_register: 2017-26987
This data as json
| document_number | title | type | abstract | publication_date | pub_year | pub_month | html_url | pdf_url | agency_names | agency_ids | excerpts |
|---|---|---|---|---|---|---|---|---|---|---|---|
| 2017-26987 | The Least Burdensome Provisions: Concept and Principles; Draft Guidance for Industry and Food and Drug Administration Staff; Availability | Notice | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "The Least Burdensome Provisions: Concept and Principles" FDA utilizes a least burdensome approach to medical device regulation to eliminate unnecessary burdens that may delay the marketing of beneficial new products, while maintaining the statutory requirements for clearance and approval. This document describes the guiding principles and recommended approach for FDA staff and industry to facilitate consistent application of least burdensome principles to the activities pertaining to products meeting the statutory definition of a device regulated under the Federal Food, Drug, and Cosmetic Act (the FD&C Act). This draft guidance is not final nor is it in effect at this time. | 2017-12-15 | 2017 | 12 | https://www.federalregister.gov/documents/2017/12/15/2017-26987/the-least-burdensome-provisions-concept-and-principles-draft-guidance-for-industry-and-food-and-drug | https://www.govinfo.gov/content/pkg/FR-2017-12-15/pdf/2017-26987.pdf | Health and Human Services Department; Food and Drug Administration | 221,199 | The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "The Least Burdensome Provisions: Concept and Principles" FDA utilizes a least burdensome approach to medical device regulation to eliminate... |