It has been a long journey for the FDA to get the new draft guidances published on when to submit a 510(k) for a change to an existing device, and another specific to software changes. But on August 8th, it finally happened! For those of you who remember the FDA's attempt at updating the 1997 Memorandum in 2011, that draft guidance was met with general industry pushback, congressional input, an FDA report to congress, and now a new draft guidance.
If you missed R&Q's Paul Robinson discuss UDI during R&Q's afternoon workshop at BIOMEDevice in April, here's a second chance. A similar presentation and discussion will be offered in conjunction with MassMEDIC on Wednesday, May 18th at 11:30am EST. All the details - including the link to register - are below!
Did you miss former FDAer Jake O'Donnell speak about avoiding and managing FDA compliance problems during R&Q's afternoon workshop at BIOMEDevice earlier this week? If so, we have news especially for you: he will be presenting on a similar topic via a webinar on Monday, May 9th at 1:00pm EST. The webinar is presented through AdvaMed, and all the details - including a link to register - are below.
There’s a formula for effectively managing an adverse FDA inspection and the newest R&Q white paper shares it. Learn all the practical considerations for avoiding regulatory escalation from a former FDA Consumer Safety Officer: R&Q's Jake O'Donnell. This is your free, ultimate compliance resource, that you can download now:
Managing An Adverse FDA Inspection: Practical Considerations for Avoiding Regulatory Escalation.
Preview the first four pages of the 24-page white paper below (click to enlarge), and download it in its entirety at the link! We hope you find the white paper valuable. If you do, be sure to share it with your colleagues and industry peers. Subscribe to R&Q's Blog to stay updated on when new white papers and other content is available.
Those in the northeast, get ready! Not only will R&Q be exhibiting at this year's BIOMEDevice show (booth 640) and sponsoring MassMEDIC's Annual Conference, but we'll be presenting an afternoon training workshop (three separate sessions) free to attendees of the BIOMEDevice show on Wednesday, April 13th from 1:00 - 4:00pm. The event will cover compliance, IVDR, and UDI... and you can choose to attend whichever session(s) you like. This will be one of R&Q's premier education events of the year and we're incredibly excited about the team we'll have on hand to share their expertise and experience, moderate discussion, and field questions. Keep on reading for complete details.
This week I will provide some information about labeling in India. CDSCO (Central Drugs Standard Control Organization) regulates the medical device industry in India. Only medical devices that CDSCO has put in the “Notified Devices Category” require registration. There are very few product types on this list and they are regulated as “drugs”. Registration is not required for import of non-notified medical devices in India. Please refer to the link below for a list of the notified device categories that must be registered in India:
If your device does not fall into one of the types on this list, it doesn’t require product registration.
For Medical Devices that do fall under Notified Devices Category (per CDSCO), products are required to have labeling as per the labeling requirements under GHTF guidelines and Rule 96 of the Drugs and Cosmetic Act, (which can be found at the following link):
In India, medical devices are categorized as “drugs”. Some of the labeling requirements in Rule 96 are specific to drugs, and will not pertain to medical devices. According to rule 96, the following items must be on the labeling for Notified Devices:
1. product description
2. number of units of contents,
3. The name of the manufacturer and the address of the premises of the manufacturer where the product has been manufactured.
4. A distinctive batch number, being preceded by the words ‘Batch No.’ or ‘B. No.’ or ‘Batch’ or ‘Lot No.’ or ‘Lot’.
5. Every product manufactured in India shall bear on its label the number of the license under which it is manufactured, the figure representing the manufacturing license number being preceded by the words “Manufcaturing Licence Number” or “Mfg. Lic. No.” or “M.L.”.
6. Date of manufacture, and the date of expiration
In addition, these products also need to comply with labeling and local laws as per Drug Price Control order and Standard Weights and Measures Act 1976 & Rules 1977.
As per Standard Weights and Measures Act 1976 & Rules 1977, the manufacturer shall indicate the following information on the package:
|1. Name and Address of Manufacturer/Importer/Packer|
|3. Generic Name of Product|
|4. Maximum Retail Price (M.R.P.) inclusive of all taxes:|
|5. Date of manufacture/ (Imported or Packed) Expiration Date|
|6. Contact information (Name, Address, Telephone Number and E-mail address) for Customer Complaint|
Most of which is redundant.
Some frequently asked questions can be found on the CDSCO website at:
Good luck with your labeling!
Why is it that Internal Audits are forgotten, or even worse feared? Why is it so many organizations of today place so much focus on the creation of Quality Procedures, Work Instructions, Forms, etc. but do not place the same focus on conducting internal audits of the quality system? Is it human nature? We all tend to be "gung-ho" about projects at the start, but the passion, and therefore the quality of the work, so often deteriorates over time.
Coming to your commercial break at the 2014 Super Bowl at Met-Life Stadium - the automated compliance robot!
'Tis the season for auditing. The beginning of this year, just like years in the past, seems to have brought the New Year's Resolution that audits will be scheduled and conducted to correct the sins of the previous year and take a fresh look at the upcoming year. To this point I've conducted three audits and after this week I'll have been the auditee twice (essentially an audit per week to start the year).
With recent clients I have been dealing more and more with new standards coming out or revisions being made to standards. This has got me thinking a lot about how to keep up with current standards. What is the best way of being notified of new releases of standards as well as interpreting and then implementing those standards?