It is the first Weekly Roundup for 2016. The decorations are down. The waistline is a bit increased. My resolutions seemed to be broken in record time this year. There is, of course, the back to work thing.
Though much of the country saw uncharacteristic warmth for the holidays, tempting daffodil shoots and other spring-like behaviors among both plants and animals, winter has returned. The sky has taken on that slate gray-blue cast that reminds us that while the light is weak and the days are short, as the season reminds us, it is time for the light to return and each day brings us closer.
In the meantime, here is a bit of what happened this week and it is all about devices:
- FDA to Hold Hearing Aid Workshop, Reopens Comment Period – The agency announced this week that it was scheduling a public workshop “Streamlining Good Manufacturing Practices for Hearing Aids” for April 21 to be held at FDA headquarters as well as re-opening public comment on a draft guidance related to the agency’s premarket requirements for hearing aids. The agency acknowledged that hearing aids are under utilized. FDA appears to be seeking to learn to what extent barriers to development of devices for use by the hearing impaired play a role in that.
- Agency Ups the Requirements on Surgical Mesh Used in Transvaginal Repair – Two final orders came out of FDA this week aimed at strengthening the data requirements on surgical mesh to repair pelvic organ prolapse transvaginally or through the vagina. One order reclassified the devices from Class II – regarded as moderate-risk devices to Class III which includes higher risk devices. The second order will require manufacturers to submit a premarket approval application with data to support safety and efficacy. The agency said it was responding to an increase seen in adverse event reporting and was following an advisory committee recommendation made five years ago that more safety data was needed.
- First Approval Announcement of 2016 – This was for a new indication – for the Integra Omnigraft Dermal Regeneration Matrix (Omnigraft) to treat certain diabetic foot ulcers. First approved in 1996 for use in burn injuries where a graft was not possible and for a new indication in 2002 when it was approved for use in patients undergoing reconstructive surgery for burns, for this indication the matrix – composed of shark cartilage, cow collagen and silicone – is placed over the diabetic ulcer to provide the basis for new skin and tissue growth. The graft cannot be used in patients with allergies to bovine collagen or cartilage.
That’s it for me this week. Next week I’ll be aiming to get out some more look-back angles at 2015, among other things. In the meantime, have a wonderful weekend.
