# Presentation: 278300

## EXPORTS	

** ****Export Reform and  Enhancement ****	****	****	****	****Act of 1996**
**                ****Casper Uldriks**
**Office of Compliance**
**Center for Devices and Radiological Health**
**FDA**

## Exporting devices not marketed in the US

**FDA Export Reform & Enhancement Act of 1996**
**Amends Chapter VIII of the Federal Food, Drug, and Cosmetic Act (the Act)**
**Section 801**
**Section 802**

## Food, Drug, and Cosmetic Act

**What’s the big deal?**
**Makes exporting easier for manufacturers**
**Adds “Import for Export” **

## Exports: 4 points to remember	

**1. Export devices marketed legally in the US (not new)**
**2. You may export devices **_**not**_** market legally in the US (new ways)**
**3. Certificates (old and new)**
**4. Import devices for export only (new)**

**Notes:**
Certificates: Not gratuitous in their context and their request.  Manufacturer could comply with the terms and each original is $175.  
Certificate for Foreign Government: products that can be legally marketed in the United Stats.  Firm and device subject to GMP inspection and the last inspection was not OAI.
No certificate if:
- Failure of the manufacturing facility to operate in compliance with the cGMP regulations (unless the product is not affected by the specific cGMP deficiencies);
The manufacturing facility is not registered or listed with FDA; and
The product is not exported from the United States.

Certificate of Exportability:  products that cannot be legally marketed in the United States, but meet the requirements of 801(e) or 802 of the Ace and may be legally exported. FDA will not issue a certificate of exportability if:
-The manufacturing facility does not comply with cGMP regulations, unless the particular exported product is not affected by the specific cGMP deficiencies. 

## Exporting devices legally marketed 

**Point #1-**
**Devices in legal domestic commercial distribution (not new)**
**Devices exported without notice to FDA**
**Certificates to Foreign Governments (CFG) – Good for business **

## Exports:Certificate to Foreign Government

- Original introduction into market
- Manufacturing site complies with cGMP
- Manufacturer has registered and listed.
- Remarketed devices excluded.

## Exporting devices not marketed in the US

**Two options**:
**Section 801(e) – the old way**
**Section 802 – the new way**

## Exports under section 801(e)(The old option – but still a good one.)

**Statutory criteria – 801(e)(1):**
- 	**1)  meet foreign purchaser’s spec’s;**
**	****	****2)  not in conflict with the laws of foreign ****	****	****country;**
**	****	**
**	****	****3)  shipping carton labeled for export; and**
**	****	**
**	****	****4)  not offered or held for sale in domestic ****	****commerce.**

## Exports under 801(e) (old option)

**801(e)(1) for class II type devices**
**The benefits:**
**Enforcement discretion on notice requirement – “Just do it.”**
**No cGMP requirement**
**“****Exportability” Certificate as an **_**OEM**_

**Notes:**
Questions:

Do remarketers qualify for a certificate of “exportability” under 801(e)(1)? No.  

Facility must be subject to FDA jurisdiction / inspectional authority.  Foreign inspections are by consent only.Note: This certificate avoids an affirmation of compliance with cGMP; it just acknowledges jurisdiction.

Do US distributors qualify for class II products produced in and shipped from a foreign facility qualify for a certificate of exportability? No.

## Export under 801(e)(1)- old option

**Certificate of Exportability**
**Device subject to FDA jurisdiction**
**Device may not be sold or offered for sale in the US**
**Meets export criteria of 801(e)(1)**

**Notes:**
Meets foreign purchaser’s specifications is difficult to determine
“Not in conflict with the laws of the foreign country” requirements is important.  Therefore, we as you to “list” the countries.  Why, a foreign country may not want certain devices that do not meet US performance standards or banned devices.  

## Export – Criteria (old or new)

**1.****	****Specifications of the foreign purchaser**
**2. ****	****Not in conflict with the laws of the ****	****foreign country**
**3.****	****Shipping carton labeled “For Export”**
**4. ****	****Not sold or offered for sale in domestic ****	****commerce**

## Exports under 802 (new option)

**Any unapproved device**
**Requires substantial compliance with cGMP  - section 802(f)**
**Also must meet 801(e)(1) criteria**
**Tier I country clearance required**

**Notes:**
Good fit for class III devices
Substantial compliant doesn’t mean perfect compliance (not OAI)
Meeting 801(e) means meeting all of the old laws requirements, including no domestic sale or distribution.
What is a “Tier I” country” and what is “clearance.”  Clearance – CE mark for legal permission to market.
FDA jurisdictional issues: 
Company is registered and has “listed” (formally identified) its products
Substantial conformance with cGMP OR international quality systems (AP Program)
Does not contain filthy substance
Not prepared, packed, or held under unsanitary conditions
Contains no dangerous or deleterious substances

Not sold or offered for sale: This means the devices are not remarketed devices.  The Certificate of Exportability is available for initial introduction in commerce – and is for export only.  No domestic activity.  No sale to an international broker, no sale to a domestic account of any kind.  801(e)(1)(D)
801(e)(1)
Labeling – in accordance with requirements of market authorization – e.g., Tier I country specifications.

## Exports under 802

**Any unapproved device? **
**Usually for class III type devices**
**Benefit? Avoids FDA’s review of safety data – which is time consuming**

## Exports under 802

**What’s **_**substantial**_** compliance with GMPs?**
**Last GMP inspection not classified as “Official Action Necessary,” e.g., **
**Warning Letter**
**Injunction – related to device**

## Exports under 802	

**Meets “old” statutory criteria**
**1. Purchaser’s specifications**
**2. No conflict with foreign country’s law**
**3. Shipping container labeled for export**
**4. Not sold or held for sale in domestic commerce**
**Worth remembering...**

## Exports under 802

**Tier I countries**
**Australia**
**Canada**
**New Zealand**
**Israel**
**Japan**
**Switzerland**
**European Economic Area**

**Notes:**
Surrogate regulatory systems.
FDA works actively with these countries.  Regular conferences with Canada.  Swiss Medic  undergoing extensive training at FDA.

## 802 -European Economic Area 

- Austria		Greece		Malta
- Belgium	Hungary	Netherlands
- Cyprus		Iceland		Norway
- Czech Rep.	Ireland		Portugal
- Denmark	Italy		Slovakia
- Estonia		Latvia		Slovenia
- Finland		Lithuania	Spain
- France		Liechtenstein	Sweden
- Germany	Luxembourg	United Kingdom
- 		More to come...	.Romania? Bulgaria?

**Notes:**
Updated as of last May to add east European countries.  
This list will grow as global commerce increases.  
FDA – global harmonization efforts for premarket and postmarket programs. 

## Exports under 802 (new option)	

- Benefits
**Faster**
**Identify device one time and go**
**Worldwide commerce**
**Covers commercial, investigational, and pipeline use.**

**Notes:**
Avoid old export provision (801(e)(2)) – lots of paper work. 
We would like to know where the device is going, although it is not required information.

## Exports under Section 802 – new option

**Certificate of Exportability –**
**Meets old export requirements (sec. 801(e)(1))**
**Device subject to FDA jurisdiction**
**Not approved for marketing in US**
**Manufacturing site subject to FDA inspection**
_**Substantial compliance**_** with cGMP **

**Notes:**
Substantial compliance does not mean “perfect compliance.”  
Not looking for the one flaw in a diamond --- you’re all diamonds!
Just need to exclude situations where Official Action is indicated. 
Even if you have a violative situation, look and see if it relates to the devices you export – and negotiate.

## Import for Export – new export program

**Section 801(d)**
**Purpose **
**Import for further manufacturing, then export (Jobs)**
**Conditional entry for articles otherwise refused entry (adulterated or misbranded)**

**Notes:**
Import for Exports takes advantage of the old export law and the new export law.  
Know ahead of time which export provision you intend to use.

## Import for Exports

**Three main elements**
**1) Notice**
**2) Records**
**3) Export or destroy**

## Notice - Imports for Exports	

**To FDA District Office (import entry)**
**Entry for further manufacturing by initial owner or consignee**
**Statement by initial owner / consignee**
**Into a device  / subassembly for export **
**Identify export authority (801 or 802)**

**Notes:**
Know whether you plan to export under old export law or the new export law before the “imported” goods arrive.  

## Records – Imports for Exports

**Maintain records that identify **_**use**_** of the components**
- Serial numbers or lot numbers, etc.
- Activities related to the “processing.”
- Identify location / possession.
**Upon FDA’s request, submit report that accounts for **_**disposition**_** of incoming articles**
_**100%**_** Accountability**

**Notes:**
Maintaining accurate records is very important
As security issues increase, accountability is important.
The requirements is related to concerns about terrorism.
Fines reflect the seriousness ($250,000)

## Export or destroy

**Any component or accessory not incorporated into a device**
**Reasonable time limitation **
- Note: US Customs Port Director may have time preference...
**Prohibited Act – Section 301(w):**
- False statement
- Domestic diversion

## Imports for exports	

- Enforcement remedies
**Administrative Detention**
**Seizure**
**Civil Money Penalties**

**Notes:**
Administrative detention is a regulatory action – usually done with the cooperation with state authorities
Seizure – immediate action for judicial decree
Civil Money Penalties – against the corporation and individuals.  

## More Information?	

**Check FDA’s Internet site for **_**E**_**xports:**
- _[http://](http://www.fda.gov/cdrh/index.html)__[www.fda.gov/cdrh/index.html](http://www.fda.gov/cdrh/index.html)_
-  **e-mail**:  **CEU@CDRH.FDA.GOV**
-  **Phone: ****	****   240-276-0100**