FDA BRIEF: Week of May 30, 2016

fda guidances

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SCOPE

FDA policy on categorizing investigational device exemption (IDE) devices to assist CMS  in determining coverage (reimbursement)

FDA INTERPREATION OF MEDICARE COVERAGE CATEGORIES A AND B

Category A: Experimental

  • No PMA approval, 510(k) clearance or de novo request has been granted
  • Proposed device has different characteristics compared to a legally marketed device
  • Proposed device is being studied for a new indication or new intended use

Category B: Nonexperimental/Investigational

  • No PMA approval, 510(k) clearance or de novo request has been granted
  • Proposed device has similar characteristics compared to a legally marketed device
  • Proposed device is being studied for a new indication or new intended use

CONSIDERATIONS FOR CHANGING FROM CATEGORY A TO B

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Inspecting for Data Integrity: From Manufacturing Floor to Quality Control Laboratories

US CFR REQUIREMENTS

  • Backup data are exact and complete, and secure from alteration, inadvertent erasures, or loss
  • Data  stored to prevent deterioration or los
  •  Certain activities documented at the time of performance
  • Laboratory controls be scientifically sound
  • True copies or other accurate reproductions of the original records
  • Complete information, complete data derived from all tests, complete record of all data, and complete records of all tests performed.

READ

INSPECTION TRENDS

  • Responsibilities andapplicable procedures not in writing or fully followed
  • Laboratory controls do not include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures
  • Failure to thoroughly review any unexplained discrepancy or the failure of a batch
  • Procedures designed to prevent microbiological contamination not established
  • No written procedures for identity, strength, quality, and purity
  • Deficient aseptic processing areas
  • Routine calibration, inspection and checking of equipment not performed

READ

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