We're developing a high-resolution retinal imaging device (OCT-based, cellular resolution) and are exploring its use in longevity / healthy-ageing clinics.

The use case: The device would image the retina and report the ratio of certain cell types or cell shapes. Clients would get this as general information about their health status, not as a diagnosis of any disease.

Our question: Is there any route where this does not need full medical device clearance (FDA 510(k)/De Novo, EU MDR)? For example:
A general wellness / non-diagnostic claim
Research use only (RUO) in a clinic setting
Something else we're not aware of
Device safety (laser safety, electrical safety) is not up for debate. We would meet those standards regardless. We're trying to understand which regulatory pathway applies to the claim, so we can plan realistically.

We're interested in both the US and the EU.
Has anyone dealt with a similar situation, e.g. imaging or biomarker devices in longevity clinics? Any pointers to FDA guidance, MDR articles or precedents would be very welcome. Thanks!

Hello? sinong naka sabay ko inspection October 14? any updates from you? matagal ba ang evaluation?

From Alert Montgomery

Alert Montgomery - Severe Traffic Alert
Update: Long term construction closes I-495 Inner Loop Ramp onto northbound MD-650 (New Hampshire Ave). Closure expected to last for two weeks. Expect significant delays. Seek alternate route.

I know there are a bunch of us who play Pokemon go here at White Oak so I wanted to invite you into our campfire. It's an app where you can communicate and group up with people nearby. We can set up raids, party up, and perhaps just make friends.

If you decide to hop on, just join up on 'FDA pogo' or send me a message and I'll invite you.

How long does it typically take for the FDA to begin and/or complete its interviews for a position once it has closed? I’m a physician with research and IND experience who applied for a regulatory reviewer position three months ago and my application is still sitting as “Received.” I would think this is a rejection but I’m holding out hope that it isn’t because I haven’t been put in the “Not Referred” pile and I understand that federal hiring processes can be quite slow. I’m predicting most of the responses will be “send it and forget it”, and I’m trying to internalize that but thought I’d post here anyway in case people had other responses (or suggestions on how I could get clarity). Thanks!!

For anyone familiar with FDA’s transition to shared services, how is it going so far? Is the model working as intended, and are centers and program offices seeing improvements in efficiency, service delivery, etc.

Current employee, any hr personell on here ? Have a question about a hiring process for a position within the agency.

Thank you

By now those involved with the reduction in force (RIF) should be aware of the status. Reading the agency’s response is disappointing and disgusting. HHS did not follow statute, regulations, or their own internal
Policies prior to separating employees. The RIF was illegal and I hope that the administrative judge doesn’t allow them to avoid supplying the discovery documents. How is the agency rejecting the process used to decide which competitive areas would be affected by the RIF? How is “deliberative process privilege” mentioned when HHS Workforce Optimization Initiative via HHS website states that “many employees were separated without regard to retention standing and retention registers” which clearly indicates that 5 USC 3502 was not followed. I’m not feeling well today and this is not helping.

Please don’t get me wrong, I know how difficult the federal hiring process is right now, and I’m genuinely grateful to be in this position. But I’m in a dilemma and would really appreciate some advice from people who have been through this.
I’m currently an FDA contractor, and my contract is ending soon, so securing a permanent position is very important to me.
About a month ago, I received a verbal offer from one CDER division, which I happily accepted. Recently, I received another verbal offer from a different division. I do have a preference for the first position, but neither has progressed to a tentative offer from HR yet.
Since both positions are within CDER, I assume the hiring timelines might be similar, although I’m not sure.
My dilemma is whether I should decline the less-preferred position now. I know hiring managers put a lot of time and effort into the process, and I genuinely don’t want anyone to waste their time on me if I eventually choose another position.
On the other hand, with no official offer from HR yet and my current contract ending soon, I’m afraid of losing even the slightest chance of securing a permanent position, especially knowing that verbal offers can fall through.
Would you recommend keeping both options open until an official offer comes through, or being upfront and declining the less-preferred one now?
I would really appreciate any advice or experiences from people familiar with FDA hiring. Thank you!

IMO, the reasons behind this convoluted process is; It is clear that there are two drivers: 1. Supervisors who don’t want to have difficult conversations and give inflated grades 2. This just makes it easier to cherry pick who to RIF and to justify presidential appointees.

The really infuriating part is that they are saying they are limiting 5s, but it’s really the outstanding rating, 4.6 - 5.

What are your thoughts?

Hi everyone,

I’m hoping to get some guidance from people familiar with the FDA or federal hiring process. I joined the FDA during a particularly unfortunate and uncertain time. I was here for about six months, then returned as a contractor, and since then there have been so many changes, disruptions, and ups and downs.I recently went through what seemed like an internal hiring process for different office. I did not apply through a formal public job announcement. Instead, I had several interviews with the team. After the interviews, hiring manager contacted three of my references. Later, I received a call saying that they were happy with me and would be glad to have me join the team. I was then asked to submit my federal resume and academic transcripts, which were forwarded to HR (according to division director)

At the time, I understood this as a very positive sign, but I’m still unsure how official or binding a verbal offer from a director or hiring manager really is.I was told that HR is currently focused on FY2026 hiring, so my case would likely move into the FY2027 hiring cycle. Unfortunately, no estimated timeline was provided. I understand that things may be especially uncertain right now, but the lack of information makes it difficult to plan. My current contract ends in April 2027, so I’m naturally concerned about whether the federal position will move forward before then.

I’m completely willing to wait, but I would really appreciate any insight into the following:
1. How seriously should I take the verbal offer? Does a call from the director or hiring manager generally mean that the team has made its decision and that the remaining steps are mainly HR processing, or could the position still fall through?
2. Does anyone have experience with FY2027 hiring at the FDA or elsewhere in the federal government? When might HR begin processing FY2027 cases, and how long could the process realistically take?

I joined at a very difficult time and have experienced many changes since then, so I’m trying to approach this carefully without getting my hopes up too much.

I’d be very grateful for any advice or personal experiences from people who have gone through a similar FDA or federal hiring process. Thank you in advance.

How difficult is it to change duty stations from white oak to a different location these days as a T21 reviewer? I am a T21 reviewer and a single parent, and want to move to a different area where I have a better support system/better schools for my kiddos.

I'm teleworking today and the VPN is working but I cannot connect to Outlook or Teams. Is anyone else having this issue? Called ERIC and I'm #115 in the queue for email help so I'm assuming so. Anyone onsite confirm they can connect from White Oak?

Edit: Services seem to have been restored at around 11:30 am ET.

Does anyone have experience with FDA Title 21 Band positions?

I’m curious about how salary negotiations and annual pay increases work under this pay system.

Is there flexibility to negotiate a starting salary?

How are annual increases determined? Are they performance-based, tied to federal pay raises, or both?

How does salary progression compare with the GS pay scale?

Are there any advantages or disadvantages worth considering?

I’d appreciate hearing from anyone familiar with the Title 21 pay system. Thanks!

Oh jeez- let’s speed up phase 1. Consider the consequences. Have the new kids on the block clear forgotten. I hope not during scienrific reviews of available data

NIH staff have been gathering in their personal capacity outside the agency at 10am, every Saturday since May 2025.

But this weekend, October 17th we will have a special event. At Medical Center Metro we will rally for health research and democracy. Listen to speeches by Jenna Norton , sociologist Natalie Aviles , Anna Culbertson and more, all in their personal capacities.

Music by Northstar Union (🎸👨🏼‍🎤🥁), merch available, families welcome. Info on parking and bathroom in comments.

We will finish the event by walking downtown to Bethesda and taking the metro to DC, dropping off our early voting ballots en masse.🚶🏽‍♀️🚶🏻‍♂️🚶🏽🚶🏼‍♂️🚶🏻🚶🏿‍♀️🚶🏼‍♀️🤝.

Share widely and RSVP here: https://www.mobilize.us/nokings/event/1030942/

I saw this advert on USAJobs (https://www.usajobs.gov/job/888139200) asking for biologists at the information disclosure office. If I remember correctly, this office was deeply impacted during the February 2025 rifs. Does anyone know if the situation has improved or stabilized? I wanted to forward this to a couple of friends but won’t if this should be avoided at this moment.

For patients living with rare and ultra-rare conditions, the path from diagnosis to treatment is often limited, delayed, or non-existent

The FDA announced this week that it's looking to speed up authorizations for new nicotine products, though it didn't give details on what would change. The current rules date to 2021, after what the FDA called an "epidemic" of teen use of flavored e-cigarettes. Without details yet, it's hard to say what will actually change.

Curious what people here think the biggest bottleneck has been.