# Presentation: 463177

## FDAEXPORT REFORMAND ENHANCEMENT ACT OF 1996Casper Uldriks 

## WHY?

- Industry claimed:
- FDA  RED  TAPE

## NEW  EXPORT LAW  FEATURES 

- IMPORT FOR EXPORT
- EXPORT OF UNAPPROVED DEVICES
- 	(for marketing or investigational use.)
- CERTIFICATIONS
- In compliance with FDA laws,
- Unapproved products may be exported under new law (802),
- Violative devices may be exported under the old law (801)(e)(1).
-  EXPORT FOR FURTHER PROCESSING
-  EXPORT FOR RARE DISEASES

## IMPORT  for  EXPORT(for further manufacturing - JOBS)

- FOR COMPONENTS & ACCESSORIES
- IMPORT  CONDITIONS:
- The finished device is for export only;
- The initial owner/importer keeps records;
- Unused components are destroyed or exported, and
- Chain of distribution documented (Bioterrorism Act.)
- WHAT’S “MANUFACTURING”?
- Broadly interpreted.
- Rule of thumb  ... an activity described in the Good Manufacturing Practices (GMP) regulations.

## EXPORT  OF  UNAPPROVED  DEVICES(802(a) & 802(b)

-   MARKET CLEARANCE IN A _TIER I_ _COUNTRY_
- 		Australia
- 		Canada
- 		Israel
- 		Japan
- 		New Zealand
- 		Switzerland
- 		South Africa
- 		European Economic Area (EEA)
- 	(OR any other country that accepts marketing authorization from a Tier I Country and also grants its own marketing authorization.)

## European  Economic  Area

- 	Austria				Luxembourg
- 	Belgium				Netherlands
- 	Denmark				Portugal
- 	Germany				Spain
- 	Greece				Sweden
- 	Finland				United Kingdom
- 	France				Iceland
- 	Ireland				Liechtenstein
- 	Italy					Norway

## EXPORT  OF  UNAPPROVED  DEVICES(802(a) & 802(b))

**How does it work?**
-  NO FDA authorization required
- 	(Conditions!)
- Send FDA “simple notification” for 1st shipment.
- Exporter maintains records with foreign
-      governments, copies of labeling and market
-      authorization.
- FDA Certification?

## CONDITIONS  FOR  EXPORT

- Registration and Listing with FDA;
- Substantial compliance with Good Manufacturing Practices or ISO 9001;
- Not “adulterated” - clean/sterile;
- Not packed or held under unsanitary conditions; and
- Does not contain any poisonous or deleterious substance.
- (more...)

## CONDITIONS  FOR  EXPORT  (Continued)

- Meets foreign purchaser’s specs.,
- Not in conflict with importing country’s law,
- Shipping package labeled for export,
- NOT offered for Sale in the U.S. (*),
- Not an eminent hazard to health,
- Labeled to meet the Tier 1 country’s specs.
- (*) The intent/decision to export must be made
- BEFORE manufacturing begins -- no seconds, no
- recalled products.

## INVESTIGATIONAL  DEVICES((802(c))

- Export to Tier I country / FDA OK not  needed,
- Compliance with U.S. investigational device exemption regulations (IDE)  not necessary.
- FDA OK is needed for export to NON-Tier I countries.

## PIPELINE   EXPORTS(Unapproved Devices In Anticipation of Market Authorization)(802(d))

- Applies to Tier I Countries only.
- Used only AFTER the firm applies for market authorization.
- May be exported for:
- formulation
- filling
- packaging
- labeling, or
- further processing! (Remember rule of thumb.)

## POINTS TO REMEMBER...

- The new export law is not an option IF:
- The unapproved device is not manufactured in substantial compliance with Good Manufacturing Practices (GMP),
- The importing country is not a TIER I Country will not accept the marketing authorization of any Tier I Country, and
- The unapproved device is to be used for investigational studies in a country that is not a TIER I Country.
- (NOTE: The GMP compliance item is the trade off for not
- having to get export clearance from FDA.  Tier I Countries
- may rely on that element to some extent.)
- What to do if 802 doesn’t work for you, e.g., export to a non
- Tier 1 Country?

## EXPORT  UNDER  THE  OLD  LAW(801(e)(2))

- Unapproved Class III devices may still be granted Export Permits by FDA.
- Requires the submission of scientific data.
- Safety assessment by FDA.
- FDA issues a written permit.
- Call (301) 827-4555 for procedures packet.
- What are a Class III devices?
- They are, “... usually those that support or sustain human
- life, are of substantial importance in preventing impairment
- of human health, or which present a potential, unreasonable
- risk of illness or injury.”  [HHS Publication FDA 96-4159 at
- page 1-4.]

## CERTIFICATION

- FDA issues Certificates for devices that:
- Comply with FDA laws:
- 	 “Certificates to Foreign Governments”
- Comply with Section 802 (new export law	“Certificate of Exportability”
- Are in violation of FDA law, but comply  with part of the old export law, the non-safety part. (801(e)(1).
- 	 “Certificate of Exportability”

## CERTIFICATION  FEE

- FDA is authorized to charge
- 	$175.00 /cert.
- FDA must issue the certificate within 20 working days to collect the fee.

## Countries  that  require  FDA  certificates  for products  for  export

- Argentina		Malaysia
- Belgium		Mexico
- Brazil			New Zealand
- Chile			Pakistan
- Colombia		Peru
- Czech Republic		Philippines
- France			Singapore
- Germany		Slovenia
- Indonesia		Spain
- Israel			Taiwan
- Italy			Thailand
- Japan			The Ukraine
- Korea			United Kingdom