Regulatory Open Forum

Is anyone aware of any signficant differences between GMP requirements of drug vs device contract manufacturers? I am looking at a situation where a 510(k) applicant plans to have the product manufactured by a vendor who is currently registered and listed in the FDA drug database but not in the device database. The vendor is hesitant to register and list in the device database because of concerns regarding an "additional certification procedure."


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Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
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Although I am not qualified to comment on the details of establishment registration, I am aware that in general the drug GMPs are more detailed and prescriptive than 21CFR820.  The principal item formally missing from 21CFR211 is a requirement for internal audits.  However, I expect that virtually all drug manufacturers would conduct such audits even if not formally required.  It should be a straightforward process to review the detailed requirements of 820 with the prospective manufacturer and to determine what items would need to be added to the quality system to ensure full compliance.  If the device is to be sold outside the US, it would be prudent to review the details of ISO 13485 as well.  Once the review is complete, the decision is likely to be an easy one for both parties.

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William White
Senior Consultant
Quality System Strategies LLC
Elkhart IN
United States
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Original Message:
Sent: 02-08-2013 08:40
From: Jean Bigoney
Subject: GMP requirements for drug vs device contract manufacturers

Is anyone aware of any signficant differences between GMP requirements of drug vs device contract manufacturers? I am looking at a situation where a 510(k) applicant plans to have the product manufactured by a vendor who is currently registered and listed in the FDA drug database but not in the device database. The vendor is hesitant to register and list in the device database because of concerns regarding an "additional certification procedure."


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Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
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Dear Jean

There are of course significant differences between drug and device regulations. For one, validation of a device is a fundamentally different concept to validating a pharmaceutical process. Also, the documentation requirements are significantly different.
Though it is possible to have both regulations covered under one Quality System, this is a significant effort.
Though certification to certain ISO standards may be necessary, this is minor in comparison to developing a brand new quality system.

Regards
Siegfried

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Siegfried Schmitt
Principal Consultant
PAREXEL
Braintree, Essex
United Kingdom
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Original Message:
Sent: 02-08-2013 08:40
From: Jean Bigoney
Subject: GMP requirements for drug vs device contract manufacturers

Is anyone aware of any signficant differences between GMP requirements of drug vs device contract manufacturers? I am looking at a situation where a 510(k) applicant plans to have the product manufactured by a vendor who is currently registered and listed in the FDA drug database but not in the device database. The vendor is hesitant to register and list in the device database because of concerns regarding an "additional certification procedure."


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Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
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Whether or not the vendor wants to "register and list in the device database", FDA is going to expect and require that the manufacturer have the appropriate quality systems in place.  As someone else indicated, there are additional requirements for devices, so they will have to demonstrate (in the application) that their current quality systems meet those requirements.

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Rachel Thornton
Associate Director
UCB
Smyrna GA
United States
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Original Message:
Sent: 02-08-2013 08:40
From: Jean Bigoney
Subject: GMP requirements for drug vs device contract manufacturers

Is anyone aware of any signficant differences between GMP requirements of drug vs device contract manufacturers? I am looking at a situation where a 510(k) applicant plans to have the product manufactured by a vendor who is currently registered and listed in the FDA drug database but not in the device database. The vendor is hesitant to register and list in the device database because of concerns regarding an "additional certification procedure."


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Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
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Dear Jean,

Legally it is not possible; your vendor must have to register facility under device regulations. FYI medical devices regulations are less stringent than drugs regulations, there is no need of hesitation(it is mandatory).

Manufacturers (both domestic and foreign) and initial distributors (importers) of medical devices must register their establishments with the FDA on an annual basis. Medical device facility registration information must be verified annually between October 1st and December 31st of each year. The failure to register or list is a prohibited act under section 301(p) of the FD&C Act (21 U.S.C. 331(p)) and the failure to do either generally renders a device misbranded under section 502(o) of the FD&C Act (21 U.S.C. 360(o))

who must register, list and pay:
http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/ucm053165.htm


Significant differences:

Drugs-
21CFR part 312- IND
21CFR part 314- NDA,ANDA
21CFR part 312- OTC
21CFR part 320- BA/BE requirements
21CFR part 210&211- Manufacturing

Devices-
21CFR part 812- IDE
21CFR part 809- IVDs
21CFR part 814- PMA
21CFR part 807, Subpart E- 510K
21CFR part 820(QSR)- Manufacturing

Shared-
Part 50 - Protection of Human Subject
Part 56 - Institutional Review Board
Part 54 - Financial Disclosure by Clinical Investigators
Part 58 - Good Laboratory Practices for Nonclinical Laboratory Studies
Part 11 - Electronic Records; Electronic Signatures

Best Regards

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Amit Jain
United States
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Original Message:
Sent: 02-08-2013 08:40
From: Jean Bigoney
Subject: GMP requirements for drug vs device contract manufacturers

Is anyone aware of any signficant differences between GMP requirements of drug vs device contract manufacturers? I am looking at a situation where a 510(k) applicant plans to have the product manufactured by a vendor who is currently registered and listed in the FDA drug database but not in the device database. The vendor is hesitant to register and list in the device database because of concerns regarding an "additional certification procedure."


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Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
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I'd like to thank everyone who replied here as well as those who replied to me privately. It has certainly been eye-opening comparing the answers with each other as well as to information received in response to a direct inquiry from the FDA.

By way of explanation, the device in question is a combination device-drug product, with primary jurisdiction in CDRH.

At any rate what I take away from this is that the potential vendor has enough to do as an FDA QSR-compliant contract manufacturer for drugs, and that the hurdles to becoming a FDA QSR-compliant manufacturer of devices are perceived as too high.

Most likely we will be looking to line up a contract manufacturer who is already registered and listed in the device database.

Again thanks to everyone for your thoughtful and helpful responses.

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Jean Bigoney PHD
Managing Member
Nu Device Consulting LLC
Newport NH
United States
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