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