Showing posts with label FDA Regulatory Procedures Manual. Show all posts
Showing posts with label FDA Regulatory Procedures Manual. Show all posts

Saturday, August 25, 2012

Outline of Recent Revisions to FDA Regulatory Procedures Manual


From the FDA website found here.

2012 Revisions and Updates

  • 08/16/2012: Chapter 9 of the Regulatory Procedures Manual1 (RPM) was revised and updated, as detailed below.
    • Chapter 9 - Import Operations and Actions
      • Section 9-1, subsection "Scope and Purpose," was revised to include the following Tobacco Acts - Federal Cigarette Labeling and Advertising Act and Comprehensive Smoking Tobacco Health and Education Act of 1986. Section 9-6, "Recommendation Based on Multiple Samples," was revised to include the amount "at least 25%" in paragraphs 1(b), 2(b), and 3(b), and to also include the following language, "FDA may consider additional information in conjunction with sample analysis when considering whether to recommend products from a manufacturer, shipper, geographic area, or country for detention without physical examination, such as the results of foreign inspections and other types of information discussed in this subchapter." Section 9-15, subsection "Background," was revised to clarify section 801(d)(3)(B) of the Act.
      • Section 9-21, Exhibits - Exhibit 9-1 was deleted so please refer to Exhibit 9-6 instead. Exhibit 9-2 was updated with the current version. Exhibit 9-3 was revised to omit "tobacco products" from the following sentence, "These laws are designed to protect you from, among other things, unsafe or misrepresented foods, drugs, biologics, cosmetics, devices, and other articles." The title of Exhibit 9-11 had the words "for Special Events" added. Exhibit 9-12 was deleted as a duplication of Exhibit 9-6. Exhibit 9-13 was removed.