Happy New Year - I hope that all of our blog readers had a wonderful holiday and brought in 2013 with warm and welcoming arms!

A New Year’s tradition of mine is to evaluate the past year’s achievements, short-comings, and non-attempts, with the hope that this assessment will lead to a solid acknowledgement on what I need to improve on. In theory, this exercise helps fuel the New Year’s resolution list, which always seems to be more demanding and initially more taxing than the previous year (no pun intended). Although the list does not always convey any sort of instant gratification, the main objective is to ultimately improve the happiness, health, and general well-being of myself and those that I surround myself with.

As I reflected on my triumphs and failures of 2012 (and they were bountiful), I realized that perhaps my lists have been too constricting and only catered to one portion of life. Seeing as life is multi-faceted, the list was bound to fall short, in certain aspects. With this notion in mind, I created the list for 2013, which is applicable to all areas of my life and focuses more on proactivity and less on restraint (Yay - already practicing Resolution 3!).

Typically, I do not reveal my resolutions to people, but I thought that it would be interesting to see how well-rounded and applicable this year’s list is by pairing it with something from the medical device world. So…. without any further ado, The List of 2013 and how each resolution can be applied to Medical Device Industry.

1.) Make healthier decisions.
No details needed.

2.) Remain prepared for the worst, but also prepare for the best.
On December 31st, 2012 the FDA issued a series of guidance documents, in order to better explain some of the key provisions from the chaos of MDUFA III (2012). Out of the three documents that were released at the end of 2012, “Refuse to Accept Policy for 510(k)s”(1) is especially noteworthy and can be interpreted as preparing for the worst case scenario (RTA), but being prepared for the best (approval).

The policy modifies the Refuse to Accept (RTA) policy to include an early review against specific acceptance criteria that is based greatly on 21 CFR §807.87 and the timeline to inform the submitter within the first 15 calendar days (after receipt of the submissions, of course!) if it is administratively complete or not. The guidance also encourages applicants to provide an eCopy, in lieu of one of the two hard copies of the 510(k) submission. Before you disregard the encouragement to submit an eCopy(2), check FDASIA, section 1136 (2012) to see if you are required to submit an eCopy (section 1136 of FDASIA requires this for most submissions, but not all). The guidance also includes checklists for traditional, abbreviated, and special 510(k)s.

Prior to submitting, two important steps should be done. The first step is to make sure that all of the acceptance criteria has been met and can be fully explained. The second step is to ensure a clear strategy in the “next-steps” for both the worst case scenario (RTA is issued) and the best case scenario (accepted for review).

3.) Embrace change with open arms and a positive attitude.
FDASIA (especially) New Device Registration and Listing Requirements(3) and the Internal Revenue Service’s Medical Device Excise Tax(4-6) are not necessarily soft, cute, and fuzzy puppies that you welcome into your arms. I couldn’t tell you one person who is ecstatic about all of FDASIA (2012) or the four dirty words, “medical device excise tax.” Some major concern regarding this tax is that it will cause manufacturers to shift production overseas. To clarify, the tax applies to domestic medical devices, as well as imported medical devices, and devices for export that are produced in the US are tax-exempt! Now, there are many variables in the decision to move a business’ production overseas and this tax alone, in theory, should not be the sole reason why a company makes that decision.

Another concern is that these two changes will inhibit innovation. Innovation will only be inhibited if we allow it to be. The medical device excise tax, coupled with comparative effectiveness research (CER), may actually create a positive impact on medical device innovation. If we look at CER in a positive light, with keeping the medical device excise tax in mind, we may be able to create more robust devices that meet the needs of the people. Such devices could be a result from existing medical device research and products, as well as listening to the needs/wants of clinicians, patients, and policymakers. If we learn to accept that this is the way of life for medical devices (at least until 2017), embrace this change, and try to make some lemonade, we may just find ourselves bringing some good to the world.

4.) Be a more active part in the community.
Regulations on medical devices and radiation-emitting electronic products are formed with the public’s help.(7) There are two avenues that the FDA gathers such vital commentary. The first pathway is by commenting on proposed rules. The second avenue is through petitions.

Proposed Rules(8)

When a revision to or creation of a rule is becomes available for public comment, the FDA publishes the announcement in the Federal Register.(9) Every weekday, the Federal Register is published and is available on the FDA website(7) and at many public libraries(10) and universities.

By commenting in writing on proposed FDA rules, anyone is can be a part of the rule-making process.

Petitions(8)

Petitions must contain the following:

- Action requested (what rule do you want FDA to issue, amend, or revoke?)

- Statement of grounds (factual grounds for the petitions and supporting material)

- Environmental impact (typically required of biologics and certain medical devices)

- Official certification statement –

"The undersigned certifies, that, to the best knowledge and belief of the undersigned, this petition includes all information and views on which the petition relies, and that it includes representative data and information known to the petition which are unfavorable to the petition."

- Identifying information (signed and include petitioner’s address and phone number)

5.) Read more content that adds to your body of knowledge.
Start by becoming familiar with the new guidance documents. Check out my references at the end of this blog for a good starting point. You will be surprised at what you will gain from reading these!

What other ways can my resolutions be applied to the medical device industry? Leave your comments below!

-RSpelich ^_^

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References
1.) FDA. Refuse to Accept Policy for 510(k)s. Rockville, MD: FDA; 2012. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM315014.pdf. Accessed 02 Jan. 2013.

2.) FDA. eCopy Program for Medical Device Submissions. Rockville, MD: FDA; 2012. Available at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM313794.pdf. Accessed 02 Jan. 2013.

3.) FDA. Food and Drug Administration Safety and Innovation Act (FDASIA). Last updated 03 Aug. 2012. Available at: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/SignificantAmendmentstotheFDCAct/FDASIA/ucm313695.htm. Accessed 2 Jan. 2013.

4.) IRS. Medical Device Excise Tax. Last updated 05 Dec. 2012. Available at: http://www.irs.gov/uac/Newsroom/Medical-Device-Excise-Tax. Accessed 02 Jan. 2013.

5.) IRS. Medical Device Excise Tax: Frequently Asked Questions. Available at: http://www.irs.gov/uac/Medical-Device-Excise-Tax:-Frequently-Asked-Questions. Accessed 02 Jan. 2013.

6.) IRS. Excise Taxes (Including Fuel Tax Credits and Refunds). Available at: http://www.irs.gov/pub/irs-pdf/p510.pdf. Accessed 02 Jan. 2013.

7.) FDA. US Food and Drug Administration Home Page. Last updated 31 Dec. 2012. Available at: http://www.fda.gov/. Accessed 01 Jan. 2013

8.) FDA. Comments on Regulations. Last updated 06 June 2009. Available at: http://www.fda.gov/AboutFDA/ContactFDA/CommentonRegulations/default.htm. Accessed 01 January 2013.

9.) FDA. FDA Federal Register (FR) Documents. Last updated 02 Jan. 2013. Available at: http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm. Accessed 01 Jan. 2013.

10.) Public Libraries. Last updated 02 Jan. 2013. Available at: http://www.publiclibraries.com/. Accessed 02 Jan. 2013.

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