FDA Is Clearing More Medical Devices — So Why Are Reviews Taking Longer?

**Medical device authorizations are increasing in 2026. But for manufacturers, the path to market may still be taking longer than expected.**

For medical device manufacturers preparing to enter the U.S. market, one question is always critical:

**How long will FDA review take?**

In 2026, that question may be becoming more complicated.

Recent industry analysis shows that the FDA has authorized more medical devices during the first half of 2026 compared with the same period in 2025. At the same time, however, average review timelines have increased for some major premarket pathways.

According to a BTIG analysis cited by MedTech industry publications, the average time to approval during the first half of 2026 was approximately **599 days for original PMA applications** and approximately **156 days for 510(k) clearances**. Both figures were longer than the corresponding 2025 averages.

So what is happening?

## More Authorizations Doesn't Necessarily Mean Faster Reviews

At first glance, these two trends seem contradictory.

**More devices are reaching the market.**

But:

**Some manufacturers are waiting longer to get there.**

This distinction is important.

FDA's Center for Devices and Radiological Health (CDRH) continues to process large numbers of submissions and has stated that it remains focused on meeting performance goals established under the Medical Device User Fee Amendments (MDUFA).

However, actual calendar time experienced by a manufacturer can be affected by much more than the FDA's formal review clock.

Submission completeness, deficiency questions, additional information requests, applicant response time, review cycles, and the complexity of the device can all influence the overall path to a final decision.

In other words:

**The FDA review clock is not always the same as your product launch clock.**

## 510(k) vs. PMA: The Timeline Difference Matters

The regulatory pathway matters significantly when planning a U.S. launch.

### 510(k)

The 510(k) pathway is generally used when a manufacturer can demonstrate that a new device is substantially equivalent to a legally marketed predicate device.

The pathway is typically faster than PMA, but that does not mean manufacturers should assume a simple 90-day journey.

The FDA's MDUFA performance framework measures specific FDA review activities and days, while the manufacturer's overall calendar timeline can be longer depending on interactions and responses during review.

### PMA

Premarket Approval (PMA) is generally required for higher-risk Class III devices.

Because PMA requires extensive evidence regarding safety and effectiveness, the process is substantially more demanding.

The 2026 industry analysis showing an average of approximately **599 days for original PMA approvals** illustrates just how significant the timeline can become for companies developing higher-risk technologies.

For a startup or emerging medical device company, an unexpected delay of several months can affect much more than the regulatory schedule.

It can affect:

- Manufacturing plans

- Investor milestones

- Clinical strategy

- Distribution agreements

- Sales forecasts

- Product launches

- Cash flow

## Why Submission Quality Matters More Than Ever

One of the biggest lessons for manufacturers is simple:

**Don't build your business plan around the fastest possible FDA scenario.**

Instead, build a regulatory strategy around the actual complexity of your device.

A submission that requires multiple rounds of clarification can create additional time and cost.

That is why preparation before submission matters.

Before submitting, manufacturers should carefully evaluate:

### 1. Regulatory pathway

Is 510(k) actually the appropriate pathway?

Could De Novo be more appropriate?

Does the device require PMA?

Choosing the wrong pathway at the beginning can create significant downstream delays.

### 2. Predicate strategy

For 510(k) devices, selecting an appropriate predicate is critical.

The substantial equivalence argument needs to be scientifically and regulatory defensible.

### 3. Testing and documentation

Electrical safety, EMC, biocompatibility, software validation, cybersecurity, sterilization, shelf life, usability, and other testing requirements may apply depending on the device.

Missing or incomplete evidence can create additional questions during review.

### 4. Labeling and intended use

The intended use, indications for use, labeling, and marketing claims need to tell a consistent story.

A mismatch between the technical documentation and the proposed claims can create unnecessary regulatory complications.

### 5. Anticipating FDA questions

A strong submission is not simply a collection of documents.

It should anticipate the questions an FDA reviewer is likely to ask.

That means identifying potential deficiencies **before** the submission reaches the agency.

## FDA's Next Move: MDUFA VI

The issue of review efficiency is also appearing in the next major chapter of FDA medical device regulation.

In July 2026, FDA and the medical device industry reached a draft agreement for **MDUFA VI**, which would establish performance goals for the 2028–2032 period.

The draft includes several noteworthy proposals.

For example, the proposed 510(k) performance goal would decrease from **128 days to 112 days** over the five-year period.

The agreement also proposes a new **Focused Follow-Up Pre-Submission** process intended to provide written FDA feedback within 45 days for certain follow-up interactions.

These changes could eventually help make the regulatory process more predictable.

But they also highlight an important point:

**Predictable review depends not only on FDA resources, but also on the quality and readiness of the submissions entering the system.**

## What Medical Device Companies Should Do Now

If you are planning a U.S. medical device launch, the takeaway isn't that you should expect FDA review to take longer for every device.

The takeaway is that **timeline assumptions need to be realistic and risk-adjusted.**

Instead of asking:

> “How quickly can we get FDA clearance?”

A better question is:

> **“What can we do before submission to reduce avoidable delays?”**

That means starting regulatory planning early, identifying the appropriate pathway, understanding applicable testing requirements, developing a defensible predicate strategy when appropriate, and making sure the submission tells one consistent technical and regulatory story.

## The Bottom Line

FDA is not simply slowing down.

The picture is more nuanced.

**More medical devices are reaching the U.S. market, while some manufacturers are experiencing longer overall review timelines.**

For medical device companies, this makes regulatory planning more important—not less.

A successful U.S. launch is not just about getting a submission into the FDA.

It is about getting the **right submission** into the FDA.

**Better preparation can mean fewer surprises, fewer review cycles, and a more predictable path to market.**

And in medical device development, predictability is often just as valuable as speed.