FDA Enforcement against Imports
John Johnson III
Associate Attorney,
Benjamin L. England & Associates, LLC
& FDAImports.com, LLC
FDA Import Enforcement Authority:
Section 801(a)
The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food,
drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving
notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right
to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of
establishments registered pursuant to subsection (i) of section 360 or section 387e(h) of this title and shall request that if any
drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so
registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be
delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear
before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination
of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in
the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of
the device do not conform to the requirements of section 360j(f) of this title, or (2) such article is forbidden or restricted in sale in
the country in which it was produced or from which it was exported, or (3) such article is adulterated, misbranded, or in violation
of section 355 of this title, or prohibited from introduction or delivery for introduction into interstate commerce under section
331(ll) of this title, or (4) the recordkeeping requirements under section 2223 of this title (other than the requirements under
subsection (f) of such section) have not been complied with regarding such article, then such article shall be refused admission,
except as provided in subsection (b) of this section. With respect to an article of food, if importation of such food is subject to, but
not compliant with, the requirement under subsection (q) that such food be accompanied by a certification or other assurance that
the food meets applicable requirements of this chapter, then such article shall be refused admission. If such article is subject to a
requirement under section 379aa or 379aa–1 of this title and if the Secretary has credible evidence or information indicating that
the responsible person (as defined in such section 379aa or 379aa–1 of this title) has not complied with a requirement of such
section 379aa or 379aa–1 of this title with respect to any such article, or has not allowed access to records described in such
section 379aa or 379aa–1 of this title, then such article shall be refused admission, except as provided in subsection (b) of this
section. The Secretary of the Treasury shall cause the destruction of any such article refused admission unless such article is
exported, under regulations prescribed by the Secretary of the Treasury, within ninety days of the date of notice of such refusal or
within such additional time as may be permitted pursuant to such regulations. Clause (2) of the third sentence of this paragraph 1
shall not be construed to prohibit the admission of narcotic drugs the importation of which is permitted under the Controlled
Substances Import and Export Act.
FDA Import Enforcement Authority:
Section 801(a) - Summarized
• Examine any food, drug, cosmetic, device, or tobacco product
• Refuse admission to any article that appears to violate
• Import alerts to ease enforcement the Act
Total Shrimp Refusals
(January through October)
Common Charges Shrimp Refusals
Salmonella Refusals
Vet. Drug Refusals
Additional Reflections
• Singular Approach?
• Essentially no overlap between vet. drugs and Salmonella
refusals
• Reliance on the Import Alert System
• Vast majority of refusals are not based on FDA testing
The draft EU medical device regulations and enhanced GMP
surveillance by Notified Bodies and Competent Authorities.
The Impact on US medical device manufacturers
FDLI Enforcement, Litigation and Compliance
Conference
December 8 - 9, 2014, Washington, DC
Phil Johnson, Senior Director
Regulatory, Quality and Compliance
Quintiles Consulting
Summary
•
The upcoming changes in GMP requirements being proposed in the
draft EU Medical Device Regulation
•
Increased compliance requirements for Notified Bodies and their
continued certification by EU Competent Authorities
• Increase in the suspension of EC Certificates for US manufacturers
and the compliance and fiscal repercussions of losing these
certificates and loss of ISO13485:2003 (GMP) certificates
• What can US manufacturers do now to mitigate this increased
surveillance by EU Competent Authorities and Notified Bodies
10
EU Regulatory environment is changing
11
EU Regulatory environment is changing
 The 3 device Directives (AIMDD, MDD, IVDMDD) will become 2 Regulations
 Regulations are directly applicable in Member States
 The Medical Device Regulation and the IVD Regulation will be accompanied by other
Implementing Regulations such as UDI and additional post-market requirements. The
EU landscape will change over the next few years. Some of the key changes are:
Increased clinical evidence requirements
More rigorous Notified Body
assessment and unannounced audits of
manufacturers and crucial suppliers
New and increased obligations for
economic operators in the supply chain
(ARs, distributors and importers)
Unique Device Identification
Changes to post-market
surveillance requirements
Pre-market authorisation of high-risk
medical devices
Requirement for Qualified Person
Increased focus on vigilance, with closer
authority cooperation, and a central EU
vigilance portal
12
EU Regulatory environment is changing
COMMISSION
RECOMMENDATION
(2013/473/EU)
COMMISSION REGULATION (EU)
No 920/2013
of 24 September 2013 on
of 24 September 2013 on
the audits and assessments
performed by notified bodies
in the field of medical devices
How Notified Bodies audit
Manufacturers
the designation and the
supervision of notified bodies
under Council Directive 90/385/EEC on active
implantable medical devices and Council
Directive 93/42/EEC on medical devices
How Competent Authorities
control Notified Bodies
13
Commission Recommendation 2013/473/EU
– Unannounced visits to the manufacturer and critical subcontractor/supplier at least
once in every three years
– Manufacturer continuously informs Notified Body when not manufacturing so NB knows when to come. Contract terminates when manufacturer can no longer
assure access to the manufacture or critical subcontractor/supplier. Contract with
critical subcontractor/supplier to allow NB unannounced visits and continuously
inform when not manufacturing
– Device testing by NB at a test lab or at the manufacturer’s site
– Product assessments for design dossiers/type exam - greater depth, including
design, manufacture, labelling, packaging, risk management, clinical
data/performance evaluation, post market plan/follow up, technical file up to date
and aligned with certificate scope
– Quality system assessments (Full, production and product QA) - greater depth ,
including technical file sample of all types over 5 years, quality system elements.
Product identification traced to devices on NB certificate, declaration of conformity,
technical file and manufacturing process
– Increased audit days and NB costs
– Contract between manufacture and NB to reflect these changes
14
FDLI Enforcement, Litigation & Compliance Conference
December 8, 2014
International Enforcement and
Compliance Initiatives
Jennifer R. Diaz, Shareholder
Board Certified in International Law
Chair, Customs and International
Trade Department
Becker & Poliakoff Law Firm
(305) 260-1053
(305) 724-3281 (cell)
JDiaz@bplegal.com
DISCLAIMER
•
This presentation is for informational purposes only and does not purport to
provide legal advice as all cases and facts are different.
•
The information in this presentation is provided “as is” and no
representations are made whatsoever.
•
You should not rely on the information included in this presentation as an
alternative to legal advice from your attorney.
•
For questions related to a specific matter, you should consult your attorney.
•
To the extent permitted by law, this presentation is Copyright © 2014 by
Becker & Poliakoff, P.A.
• Expediting your supply chain
– Interplay Between CBP and
FDA
• Future of C-TPAT
• NEW Trusted Trader Pilot
Program
– NEW Benefits
• Top rationales for FDA
detentions upon Importation
DHS is responsible for:
• Managing the nation's borders and ports-of-entry.
– Preventing the passage of individuals or goods from entering the
United States unlawfully.
– Working overseas to strengthen U.S. defenses against illegal
smuggling and immigration.
• DHS includes the U.S. Customs and Border Protection (CBP)
which is the single, unified border agency of the United States
Government.
– CBP and is responsible for border security—including
antiterrorism, immigration, anti-smuggling, trade compliance, and
agriculture protection—while simultaneously facilitating the
lawful trade and travel at U.S. ports of entry that is critical to our
Nation’s economy.
CUSTOMS TRADE PARTNERSHIP
AGAINST TERRORISM
•
•
•
•
Voluntary government-business initiative - 2002.
Goal: strengthen and improve overall international supply
chain security, U.S. border security and minimize the
threat of terrorism in the U.S.
Private companies submit to CBP a company profile and
security profile including proof that certain security
measures have been made to prevent terrorists or terrorist
weapons from attempting to enter the U.S.
Customs “certifies” membership of the applicant as a CTPAT member.
Customs-Trade Partnership
Against Terrorism (C-TPAT)
• Currently over 10,756
participants
• Businesses eligible to apply
for C–TPAT membership
include:
– U.S. importers of record;
– Mexican and Canadian
manufacturers;
– Licensed U.S. customs
brokers;
– U.S. marine port
authority/terminal
operators;
– Carriers… and more
•
C–TPAT incentives are
based on 3 tier structure.
– Tier I to importer partners
that have been certified;
– Tier II to certified AND
validated
– Tier III to importers who
have exceeded the
program’s requirements
•
334
– 2013 2131 total validations
conducted
C-TPAT
• Reduced frequency of examinations and time in cargo
secondary inspection lines.
– Tier III C-TPAT partners are 9 times LESS likely to undergo a
security based examination
– Tier II C-TPAT partners are 3.5 times LESS likely
• Reduced time and cost of getting goods released.
• Point of contact person assigned by CBP specifically to
company (SCSS).
• Reduced penalties.
• Improved security for workforce.
• Viewed as better citizen in the trade community
(marketability and mutual recognition).
Importer Self Assessment (ISA)
•
•
•
•
•
•
•
•
•
A voluntary approach to trade compliance
Open to US and Canadian importers
The ISA program is a trade facilitation partnership
between CBP and importers
Highly compliant importers who have made a
commitment to comply with Customs laws and
regulations in exchange for benefits.
A voluntary approach to trade compliance that allows
importers to maximum control of their own CBP
compliance.
Recognizes importers who are willing to assume
responsibilities for self-assessment in exchange for
less CBP oversight.
After initial CBP review by Auditors, importers are
responsible for monitoring their own compliance and
reporting any errors to CBP.
Benefits include removal from the audit universe and
enhanced prior disclosure benefits.
ISA participants must also be C-TPAT certified
(security partnership).
ISA
•
•
•
•
•
•
Exemption from comprehensive audits
Less CBP Intrusion
Coverage for multiple business unites
Greater business certainty
Enhanced prior disclosure
Participation can be considered mitigating factor
for penalties or liquidated damages
• National account manager
Trusted Trader Program
Trusted Trader Program
• CBP, FDA, & CPSC are working together!
• In Pilot stage now
• Will replace ISA (but, not C-TPAT)
• Additional incentives (above C-TPAT &
ISA):
–
–
–
–
–
–
Reduced FDA targeting/examination risk score
Penalty offsets
Reduced FTZ inspections
Exempt from random non-intrusive Inspections
Choice of exam locations (other than port of arrival)
Release of merchandise no subject to further
examination
– CPCS benefits (including a point of contact)
– AND MORE…
MULTIPLE PORTS OF ENTRY? CEE
CEE Locations
TOP FDA ISSUES for
FOOD PRODUCTS/ DIETARY
SUPPLEMENTS*
• Non-Compliant Labeling*
Manufacturer failure to
register – FDA
(www.FDA-USA.com)
• No registration for Low
Acid Canned Foods
• Subject to Import Alert*
TOP FDA ISSUES for
COSMETICS/DRUGS*
• Non-compliant labeling*
• Subject to import alert*
• Non-permitted color
additive
• Contaminated and unsafe
• Manufactured in unsanitary
conditions (GMP’s)
TOP FDA ISSUES for
MEDICAL DEVICES
• The manufacturer and/or
initial importer is not
registered with the FDA
• The device is not listed with
the FDA
• The product does not
contain 510k clearance or
PMA
• Assure CORRECT
affirmation of compliance
codes used in PREDICT
• Product labeling is not
compliant
Do you have questions about importing and exporting?
Visit and subscribe to my blog at
www.customsandinternationaltradelaw.com
Now That We Have Our Paws
Dirty… Any Questions?
FDLI Enforcement, Litigation & Compliance Conference
December 8, 2014
International Enforcement and
Compliance Initiatives
Jennifer R. Diaz, Shareholder
Board Certified in International Law
Chair, Customs and International
Trade Department
Becker & Poliakoff Law Firm
(305) 260-1053
(305) 724-3281 (cell)
JDiaz@bplegal.com
The draft EU medical device regulations and enhanced GMP
surveillance by Notified Bodies and Competent Authorities.
The Impact on US medical device manufacturers
FDLI Enforcement, Litigation and Compliance
Conference
December 8 - 9, 2014, Washington, DC
Phil Johnson, Senior Director
Regulatory, Quality and Compliance
Quintiles Consulting
Summary
•
The upcoming changes in GMP requirements being proposed in the
draft EU Medical Device Regulation
•
Increased compliance requirements for Notified Bodies and their
continued certification by EU Competent Authorities
• Increase in the suspension of EC Certificates for US manufacturers
and the compliance and fiscal repercussions of losing these
certificates and loss of ISO13485:2003 (GMP) certificates
• What can US manufacturers do now to mitigate this increased
surveillance by EU Competent Authorities and Notified Bodies
35
EU Regulatory environment is changing
36
EU Regulatory environment is changing
 The 3 device Directives (AIMDD, MDD, IVDMDD) will become 2 Regulations
 Regulations are directly applicable in Member States
 The Medical Device Regulation and the IVD Regulation will be accompanied by other
Implementing Regulations such as UDI and additional post-market requirements. The
EU landscape will change over the next few years. Some of the key changes are:
Increased clinical evidence requirements
More rigorous Notified Body
assessment and unannounced audits of
manufacturers and crucial suppliers
New and increased obligations for
economic operators in the supply chain
(ARs, distributors and importers)
Unique Device Identification
Changes to post-market
surveillance requirements
Pre-market authorisation of high-risk
medical devices
Requirement for Qualified Person
Increased focus on vigilance, with closer
authority cooperation, and a central EU
vigilance portal
37
EU Regulatory environment is changing
COMMISSION
RECOMMENDATION
(2013/473/EU)
COMMISSION REGULATION (EU)
No 920/2013
of 24 September 2013 on
of 24 September 2013 on
the audits and assessments
performed by notified bodies
in the field of medical devices
How Notified Bodies audit
Manufacturers
the designation and the
supervision of notified bodies
under Council Directive 90/385/EEC on active
implantable medical devices and Council
Directive 93/42/EEC on medical devices
How Competent Authorities
control Notified Bodies
38
Commission Recommendation 2013/473/EU
– Unannounced visits to the manufacturer and critical subcontractor/supplier at least
once in every three years
– Manufacturer continuously informs Notified Body when not manufacturing so NB knows when to come. Contract terminates when manufacturer can no longer
assure access to the manufacture or critical subcontractor/supplier. Contract with
critical subcontractor/supplier to allow NB unannounced visits and continuously
inform when not manufacturing
– Device testing by NB at a test lab or at the manufacturer’s site
– Product assessments for design dossiers/type exam - greater depth, including
design, manufacture, labelling, packaging, risk management, clinical
data/performance evaluation, post market plan/follow up, technical file up to date
and aligned with certificate scope
– Quality system assessments (Full, production and product QA) - greater depth ,
including technical file sample of all types over 5 years, quality system elements.
Product identification traced to devices on NB certificate, declaration of conformity,
technical file and manufacturing process
– Increased audit days and NB costs
– Contract between manufacture and NB to reflect these changes
39
Notified Body Audit Results
EC Certificate Withdrawals % issued
5.0%
951 from 21,530
4.0%
4.2%
3.0%
2.0%
230 from 13,889
1.0%
1.7%
0.0%
2010
2012
The European Association Medical devices – Notified Bodies, Team NB: Survey 2012 http://www.team-nb.org/documents/2013/TEAM-NB-MD-2012-Survey.pptx
40
Impact of EC Certificate/ISO13485 withdrawal
EC Certificate
ISO 13485:2003 Certificate
•
Would deny a manufacturer access
to market in all the EEA Member
States
• Impact on maintaining EC Certificate
where full quality assurance is
required
•
Brings concern and attention from
other Regulatory Authorities
•
• Deny access to Brazil and Canada
and other countries where ISO13485
is mandated
Australia, Saudi Arabia, China and
other countries have a simpler
registration process if devices are
approved in the EU. Withdrawal of
an EC Certificate may affect
registration in other countries
• Health Authority tenders for devices
require ISO13485 to complete
contracting
41
Impact on US Medical Device Manufacturers
• Manufacturers face increased challenges to maintaining CE Marking
and ISO 13485 Quality System Certifications
• Companies bringing innovative product to market face steeper
regulatory challenges as new regulatory framework becomes effective
and early adoption of some of the requirements
• NB and ISO quality system audits are considered to be less stringent
compared with FDA inspections. That view is changing and
manufacturers need to consider audit failure as a threat to business
continuity not just for the EU
• The changing requirements introduce more control of Notified Bodies
by the EU Competent Authorities, resulting in more control of
manufacturers by Notified Bodies
42
What US manufacturers can do now
Review and understand Commission Recommendation 2013/473/EU and
inform all stakeholders of the impact
Start preparing for Notified Body unannounced audits and review contracts with
critical suppliers
Draft processes / procedures for receiving Notified Bodies (base it on existing
FDA practices)
Review critical subcontractors and crucial supplier contracts, amend for
unannounced audits Check readiness of sub-contractors to react to
unannounced audits (mock audits)
Plan now for any product reviews by your NB. Lead times will be longer and
reviews will be more exhaustive. Good technical files will speed the process
Factor additional visit costs in to budget processes, including any critical
suppliers . Clarify the needs with your NB now
43
Questions?
11