21 U.S.C. § 4.4 - How can I comply with these current good manufacturing practice requirements for a co-packaged or single-entity combination product?

Cite as21 U.S.C. § 4.4
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10 practice notes
  • Alternative or Streamlined Mechanisms for Complying With the Current Good Manufacturing Practice Requirements for Combination Products; Proposed List Under the 21st Century Cures Act
    • United States
    • Federal Register June 13, 2018
    • June 13, 2018
    ...manufacturing processes for which ``good manufacturing processes'' may be adopted that vary from the requirements set forth in Sec. 4.4 (21 CFR 4.4) or that FDA proposes can satisfy the requirements in Sec. 4.4 through ``alternative or streamlined mechanisms,'' and to review this list perio......
  • Medical Devices; Quality System Regulation Amendments
    • United States
    • Food And Drug Administration
    • Invalid date
    ...of ISO 13485 does not create inconsistencies with other applicable FDA requirements. FDA is also proposing conforming edits to part 4 (21 CFR part 4) to clarify the device QMS requirements for combination products. These edits would not impact the CGMP requirements for combination products.......
  • FDA 2017 Year In Review
    • United States
    • Mondaq United States
    • January 22, 2018
    ...demonstrate compliance with the drug cGMPs and medical device QSR requirements through one of the streamlined approaches outlined in 21 CFR § 4.4(b). In 2017, the most common violations cited in CDER's Office of Manufacturing Quality's Warning Letters were data integrity deviations and issu......
  • FDA 2017 Year in Review
    • United States
    • JD Supra United States
    • January 12, 2018
    ...demonstrate compliance with the drug cGMPs and medical device QSR requirements through one of the streamlined approaches outlined in 21 CFR § 4.4(b). In 2017, the most common violations cited in CDER’s Office of Manufacturing Quality’s Warning Letters were data integrity deviations and issu......
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7 firm's commentaries
  • FDA 2017 Year In Review
    • United States
    • Mondaq United States
    • January 22, 2018
    ...demonstrate compliance with the drug cGMPs and medical device QSR requirements through one of the streamlined approaches outlined in 21 CFR § 4.4(b). In 2017, the most common violations cited in CDER's Office of Manufacturing Quality's Warning Letters were data integrity deviations and issu......
  • FDA 2017 Year in Review
    • United States
    • JD Supra United States
    • January 12, 2018
    ...demonstrate compliance with the drug cGMPs and medical device QSR requirements through one of the streamlined approaches outlined in 21 CFR § 4.4(b). In 2017, the most common violations cited in CDER’s Office of Manufacturing Quality’s Warning Letters were data integrity deviations and issu......
  • FDA Issues Final Rule Regarding CGMPs for Combination Products
    • United States
    • JD Supra United States
    • February 4, 2013
    ...of the QSR that are not covered by the drug CGMPs, including design controls, purchasing controls, installation and servicing. See 21 C.F.R. § 4.4(b)(1) for the complete list of additional QSR requirements. On the other hand, the manufacturer could choose to follow all of the requirements o......
  • Current Good Manufacturing Practice Rule for Combination Products Issued by FDA
    • United States
    • LexBlog United States
    • January 25, 2013
    ...that chooses to comply (or that has already complied) with the device QSR need only abide by those additional regulations listed in 21 C.F.R. 4.4(b)(2), rather than attempting to address the entire drug CGMPs (or determine which CGMPs are applicable). There is no such option for combination......
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