FDA To Inspect Facilities Using Novel Sterilization Methods

The FDA has released this guidance document:

Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile - Guidance for Industry and Food and Drug Administration Staff

"We believe that novel sterilization technologies carry a substantial risk of inadequate sterility assurance if not conducted properly. Consequently, compliance with GMP for devices sterilized using these technologies should be closely evaluated. Failure to assure sterility presents a serious risk to human health because of the risk of infection. Therefore, we intend to inspect the manufacturing facility before clearing a 510(k) for a device that is sterilized by a novel sterilization process. Inspecting the manufacturing facility for devices sterilized using these sterilization technologies will help ensure the safety and effectiveness of these devices and mitigate the risks to human health."

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FDA outlines cybersecurity recommendations for medical device manufacturers

Read the full article:  Press Announcements > FDA outlines cybersecurity recommendations for medical device manufacturers - FDA.gov:

"The U.S. Food and Drug Administration today issued a draft guidance outlining important steps medical device manufacturers should take to continually address cybersecurity risks to keep patients safe and better protect the public health. The draft guidance details the agency’s recommendations for monitoring, identifying and addressing cybersecurity vulnerabilities in medical devices once they have entered the market. The draft guidance is part of the FDA’s ongoing efforts to ensure the safety and effectiveness of medical devices, at all stages in their lifecycle, in the face of potential cyber threats."

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Read the FDA draft guidance:
Postmarket Management of Cybersecurity in Medical Devices (PDF)

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FDA - Proposed 2016 Guidance Development & Focused Retrospective Review of Final Guidance

According to the FDA:

" . . .guidance documents that CDRH intends to publish this fiscal year (FY2016), as well as previously-issued final guidances for which CDRH is interested in receiving external feedback regarding whether these final guidances should be revised or withdrawn. We have provided three lists: (1) a list of guidance documents that the Agency fully intends to publish (the “A-list”); (2) a list of guidance documents that the Agency intends to publish as resources permit (the “B-list”); and (3) a list of final guidance documents that issued in 2006, 1996, 1986, and 1976 subject to focused retrospective review."

Go to this FDA webpage:
CDRH Fiscal Year 2016 (FY 2016) Proposed Guidance Development and Focused Retrospective Review of Final Guidance


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F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval - The New York Times

Read the full article: F.D.A. Regulator, Widowed by Cancer, Helps Speed Drug Approval - The New York Times:

"In her struggle with cancer and ultimately her death in November, Ms. Pazdur had a part, her husband and a number of cancer specialists now say, in a profound change at the F.D.A.: a speeding up of the drug approval process. Ms. Pazdur’s three-year battle with cancer was a factor, they say, in Dr. Pazdur’s willingness to swiftly approve risky new treatments and a passion to fight the disease that patient advocates thought he lacked."

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