On October 24, FDA finalized two guidances offering insight into when a new 510(k) is required following changes made to medical devices or the software powering them.

The drafts of these two guidances were released in the fall of 2016, five years after FDA's initial attempt at replacing its 1997 guidance outlining 510(k) changes. Deciding When to Submit a 510(k) for a Change to an Existing Device (“2016 Device Change Guidance”) revised FDA's 1997 guidance of the same name. The other, Deciding When to Submit a 510(k) for a Software Change to an Existing Device (“2016 Software Device Change Guidance”), presents guidelines for particular software changes.

Regulators have stated that the final versions of the guidances have been updated for clarity and to ensure they are interpreted consistently by agency staff and device manufacturers.

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The HHS Office of Human Research Protections is delaying by one year the implementation deadline for changes in the common rule, the regulations that govern human subjects research.

  • The new effective date will be early in 2019, rather than January 19, 2018.
  • The Federal Register notice announcing the delay is currently under review at OMB and should be published shortly.
  • NIH’s policy on single IRBs of record remains in place.

On Wednesday, NIH issued guidance on the use of Single Institutional Review Boards as well as guidance on requests for an exception to the NIH Policy on the Use of a Single Institutional Review Board (sIRB) for Multi-Site Research.

We've highlighted some key points from these guidances below.

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Since regulators have began putting greater scrutiny on compounding pharmacies following incidents linked to poor oversight by state boards of pharmacy, FDA has divided these pharmacies into two sectors: 503A and 503B.

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