Regulatory Open Forum

RE: bundling disparate sutures

What is your rationale about safety and efficacy "not" differing significantly when the suture materials are different?  What evidence do you have to convince a reviewer about the similar strength, biocompatibility, etc. across these various suture types (e.g., how do you compare absorbable "gut" suture and nonabsorbable polypropylene suture)?  These do not seem to have the same safety and performance profiles and the uses seem to differ(e.g., between absorbable and nonabsorbable sutures – does the later need to be removed while the former does not?).  Your question does not seem straight forward and should consider FDA guidance on this topic (e.g. looks like this is where you retrieved your table: Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Surgical Sutures; available at: http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm072698.htm).  Note that each type has a separate regulation and your testing should detail the physical and performance characteristics for each type.

I would challenge your thinking on your statement "they do not differ significantly in purpose, design, function, or any other feature related to safety and effectiveness, excepts for materials."  An opposite opinion might be they EACH differ significantly in purpose, design, function and other features related to safety and effectiveness BECAUSE they are made of different materials.

Cheers!

Joy Frestedt, PhD, RAC, CPI, FRAPS

President and CEO

Frestedt Incorporated

9445 Minnetonka Boulevard

St. Louis Park, MN 55426

952-426-1747 office phone

952-426-1757 fax

612-219-9982 cell phone

jf@frestedt.com

www.frestedt.com

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Hi Leo,

My experience specific to suture 510(k)s : it is a tedious/busy submission, but you can bundle all the absorbables into one 510k (and the non-absorbables into another). Not easy, but not impossible. 

And be prepared for a lot of detailed questions from the reviewer.

Art

A. Arthur Rankis, President

A. A. Rankis & Associates, Inc.

Acton, MA 01720-5331, USA

David,

You hit the nail on the head with … "doable under the assumption that the firms have all the necessary data".

Having all the necessary data (and labeling done properly) Is usually what falls short and complicates this situation.

Art

I think we need to be careful when we discuss bundling, as there many cases where it is helpful to both the manufacturer and FDA – for instance, in a Special 510(k) or PMA supplement when several devices use common components that are being changed and the data establishing S&E is the same across the products or product lines. It does become much more of a challenge when trying to bundle original submissions for multiple devices together, even when they fall in the same procode – and I have heard FDA say they do not believe original submissionsshouldn be bundled across procodes.

Ginger Glaser, RAC

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Regarding the tedious and busy nature of the submission and the many questions from the reviewers, I can't speak to 510(k)s, but otherwise I've found that bundling often doesn't turn out to be the great thing it might appear to be.  It depends in part on how much revenue you anticipate from the bundled devices once they are clear, but sometimes it just isn't worth saving on the user fees to risk having all the devices held up because FDA has questions about just one of them.

When it comes to saving, it fits that this would not be consistent with MDUFA.  User fees are supposed to help pay for FDA resources needed to review submissions.  It is probably not going to take FDA appreciably less time (and maybe even more, depending on how well organized the submission might be) to review the data to support x devices in one submission than the same data presented in x separate submissions.  This practice would probably not be looked upon kindly by companies who dutifully pay fees for each separate submission, and would probably see bundling as a means by which one company soaks up FDA resources without having paid for them, leaving less resources for everybody else.  If MDUFA closed that door, it was probably with this potential disparity in mind.