article thumbnail

What to Expect During a Primary Care Visit

Mesa Family Physician

This blog covers everything you need to know—from appointment types and coding to telehealth options and what really happens during your time with the provider. Typically, it includes a full review of your medical history, a physical examination, and a conversation about lifestyle, medications, and future health goals. Absolutely.

article thumbnail

Electronic 510(k) Submissions Ahead (FINALLY!)

FDA Law Blog

Mullen — Last month, FDA announced two important steps towards accepting electronic 510(k) submissions. As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year. As discussed in an earlier post ( here ), CDRH piloted the eSTAR electronic submission template last year.

Insiders

Sign Up for our Newsletter

This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.

article thumbnail

Submitting a 510(k)? Keep Hoarding Blank CDs

FDA Law Blog

Lenz, Senior Medical Device Regulation Expert — FDA introduced electronic copies (eCopies) of 510(k)s in 2013 (see our prior blogs here and here ) as a way to reduce the need for submission of paper copies of 510(k)s to the Agency. This pilot program, which utilized FDA’s eSubmitter electronic submission template, ended in May 2021.

article thumbnail

FDA Hosts Webinar for Stage 1 Requirements under LDT Final Rule

FDA Law Blog

See our prior blog post summarizing the different phaseout stages and categories of enforcement discretion. After a lab submits an MDR, FDA said that laboratories should save the electronic “Acknowledgement 3” (Ack3) generated after submitting an MDR in the MDR event files. It should be noted that 21 CFR 803.18(b)(1)(ii)

article thumbnail

You don’t need X-Rays in a child with bronchiolitis, croup, asthma, or first time wheezing

PEMBlog

This is a blog post and a podcast episode designed to disseminate the important work of Choosing Wisely , an initiative of the the American Board of Internal Medicine Foundation, the goal of which is the spark conversations between clinicians and patients about what tests, treatments, and procedures are needed – and which ones are not.

Asthma 52
article thumbnail

Be The Market: How Doctors Should Invest Their Money

The Motivated MD

The Three Fund Portfolio This is where we ultimately return to an investment strategy I have written about previously on this blog. You spend your life dedicated to patient care while still hoping to leave work and have the energy to be mentally and physically present for your families and friends.

Finance 52
article thumbnail

Logistics Unwrapped: A Roadmap to Successful FDA Meetings in In-Person and Hybrid Formats

FDA Law Blog

CDRH recently announced its acceptance and hosting of in-person meetings, including hybrid options that allow for both physical and virtual participation. Additionally, recent visitors did not have to scan their identification cards through an electronic machine. Our recent experiences indicate that is no longer the practice.